Effects of Oncological Treatment During Pregnancy on Mother and Child

NCT00330447 | Recruiting

• 1 other identifier: cancer in pregnancy
• Study Type: observational
• Target: 5,000
• Locations: 19 countries
• Sites: 32

Brief Summary

The researchers aim to investigate the outcome (overall survival) of mothers who are diagnosed and/or treated for cancer during pregnancy. Furthermore they want to test the hypothesis that children who were exposed to cancer or cancer treatment (cytotoxic drugs, radiation therapy, targeted therapy,...) develop normally (neurologic and cardiologic examination).

Conditions

Cancer; Pregnancy

Keywords

pregnancy; in utero; chemotherapy; radiotherapy; cancer; offspring; neonatal; long term; follow up; cancer during pregnancy; chemotherapy and radiotherapy during pregnancy; long term follow up of children

Outcome Measures

Primary Outcomes (2)

• Follow-up of the mothers diagnosed with cancer during pregnancy

  treatment during pregnancy, obstetrical outcome, maternal survival

  anticipated

• Follow-up of the children antenatally exposed to chemotherapy or radiotherapy

  neurologic and cardiologic outcome

  anticipated

Study Arms (2)

Studygroup

Cancer in Pregnancy - all diagnoses and treatments Children born from mothers diagnosed with cancer during pregnancy

Control group

Children from the general population

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Premenopausal women with a cancer diagnosis in association with cancer

You may qualify if:

• Histologically proven cancer in association with a pregnancy (during pregnancy or cancer dagnosis within 5 years after pregnancy)
• \> 18 years of age, premenopausal
• Patients who have given their signed and written informed consent to participate in the trial after fully understanding the implication of the protocol
• Women receiving any cytotoxic drug or radiation therapy during pregnancy are allowed for the assessment of the maternal and fetal outcome (Part II).

You may not qualify if:

• Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent
• \*\*\*\*\*\*\*\*\*\*\*\*\*\*Part II: Follow-up of children\*\*\*\*\*\*\*\*\*\*\*\*\*\*
• \- Children that were prenatally exposed to cancer of cancer treament. Informed Consent is asked from parents. From the age of 12 years, informed assent is additionally asked from the child. After the age of 18 years, informed consent is solely asked of the offspring.
• Mentally disabled or significantly altered mental status that would prohibit the understanding and giving of informed consent

Sponsors & Collaborators

• University Hospital, Gasthuisberg: lead
• The Netherlands Cancer Institute: collaborator
• Erasmus Medical Center: collaborator
• San Gerardo Hospital: collaborator
• Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico: collaborator
• Charles University, Czech Republic: collaborator

Study Sites (33)

Cooper University Hospital (2015-ongoing)

Camden, New Jersey, 08103, United States

RECRUITING

Instituto Alexander Fleming

Buenos Aires, Argentina

WITHDRAWN

Universitätsklinik für Frauenheilkunde und Geburtshilfe (retrospective 2016-2018)

Graz, Austria

TERMINATED

UCL Brussels (2013-ongoing)

Brussels, Belgium

RECRUITING

UZ Gasthuisberg, Katholieke Universiteit Leuven (2004-ongoing)

Leuven, 3000, Belgium

RECRUITING

University Hospital Ostrava (2018-ongoing)

Ostrava, Czechia

RECRUITING

3rd medical faculty of Charles University (2010-ongoing)

Prague, Czechia

RECRUITING

Copenhagen University Hospital (2015-ongoing)

Copenhagen, Denmark

RECRUITING

Hopital Bichat-Claude-Bernard (retrospective until 2018)

Paris, France

TERMINATED

Universitätsklinik Freiburg (retrospective until 2018)

Freiburg im Breisgau, Germany

TERMINATED

Euroclinic Hospital (2016-ongoing)

Athens, Greece

RECRUITING

Hellenic Anticancer-Oncological Hospital of Athens (retrospective 2015-2018)

Athens, Greece

TERMINATED

Ioannina University Hospital (retrosepctive 2015-2018)

Ioannina, Greece

TERMINATED

Hippokration Hospital (retrospective 2015-2018)

Thessaloniki, Greece

TERMINATED

European Institute of Oncology (2010-ongoing)

Milan, Italy

RECRUITING

Fondazione IRCCS Ca'Granda Ospedale Maggiore (2012-ongoing)

Milan, Italy

RECRUITING

Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico Milano (2017-ongoing)

Milan, Italy

RECRUITING

San Raffaele Hospital (2017-ongoing)

Milan, Italy

RECRUITING

CIttà della Salute e della Scienza di Torino (2015-ongoing)

Torino, Italy

RECRUITING

Regional Hospital of High Specialty of Ixtapaluca (2018-ongoing)

Ixtapaluca, 56530, Mexico

RECRUITING

Erasmus Medical Center (2014-ongoing)

Rotterdam, Netherlands

RECRUITING

Haukeland University Hospital (2017-ongoing)

Bergen, Norway

RECRUITING

Medyczne Macierzynstwo (retrospective 2010-2018)

Krakow, Poland

TERMINATED

University Hospital Krakow (2018-ongoing)

Krakow, Poland

RECRUITING

Pozanan University of Medical Sciences (2017-ongoing)

Poznan, Poland

RECRUITING

Hospital de Vila Franca de Xira (2017-ongoing)

Vila Franca de Xira, Portugal

RECRUITING

N.N.Blokchin National Medical Research Center of Oncology (2013-2018 retrospective; 2018-ongoing prospective)

Moscow, Russia

RECRUITING

Research Center for Obstetrics, Gynecology and Perinatology (2014-ongoing)

Moscow, Russia

RECRUITING

Almazov National Medical Research Center (2018-ongoing)

Saint Petersburg, Russia

RECRUITING

Karolinska University Hospital (2017-ongoing)

Stockholm, Sweden

RECRUITING

F.Hached University Teaching Hospital (retrospective 2016-2018)

Sousse, Tunisia

TERMINATED

Trakya University Faculty of Medicine (retrospective 2015-2018)

Edirne, Turkey (Türkiye)

TERMINATED

Grigoriev Institute for medical Radiology (retrospective until 2018)

Kharkiv, Ukraine

TERMINATED

Related Publications (72)

• Caluwaerts S, VAN Calsteren K, Mertens L, Lagae L, Moerman P, Hanssens M, Wuyts K, Vergote I, Amant F. Neoadjuvant chemotherapy followed by radical hysterectomy for invasive cervical cancer diagnosed during pregnancy: report of a case and review of the literature. Int J Gynecol Cancer. 2006 Mar-Apr;16(2):905-8. doi: 10.1111/j.1525-1438.2006.00223.x.

  PMID: 16681782 BACKGROUND

• Van Calsteren K, Berteloot P, Hanssens M, Vergote I, Amant F, Ganame J, Claus P, Mertens L, Lagae L, Delforge M, Paridaens R, Noens L, Humblet Y, Vandermeersch B, De Muylder X. In utero exposure to chemotherapy: effect on cardiac and neurologic outcome. J Clin Oncol. 2006 Apr 20;24(12):e16-7. doi: 10.1200/JCO.2006.06.1382. No abstract available.

  PMID: 16622256 BACKGROUND

• Lishner M, Avivi I, Apperley JF, Dierickx D, Evens AM, Fumagalli M, Nulman I, Oduncu FS, Peccatori FA, Robinson S, Van Calsteren K, Vandenbroucke T, Van den Heuvel F, Amant F. Hematologic Malignancies in Pregnancy: Management Guidelines From an International Consensus Meeting. J Clin Oncol. 2016 Feb 10;34(5):501-8. doi: 10.1200/JCO.2015.62.4445. Epub 2015 Nov 30.

  PMID: 26628463 BACKGROUND

• Amant F, Verheecke M, Wlodarska I, Dehaspe L, Brady P, Brison N, Van Den Bogaert K, Dierickx D, Vandecaveye V, Tousseyn T, Moerman P, Vanderstichele A, Vergote I, Neven P, Berteloot P, Putseys K, Danneels L, Vandenberghe P, Legius E, Vermeesch JR. Presymptomatic Identification of Cancers in Pregnant Women During Noninvasive Prenatal Testing. JAMA Oncol. 2015 Sep;1(6):814-9. doi: 10.1001/jamaoncol.2015.1883.

  PMID: 26355862 BACKGROUND

• de Haan J, Verheecke M, Amant F. Management of ovarian cysts and cancer in pregnancy. Facts Views Vis Obgyn. 2015;7(1):25-31.

  PMID: 25897369 BACKGROUND

• Amant F, Han SN, Gziri MM, Vandenbroucke T, Verheecke M, Van Calsteren K. Management of cancer in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2015 Jul;29(5):741-53. doi: 10.1016/j.bpobgyn.2015.02.006. Epub 2015 Mar 4.

  PMID: 25797199 BACKGROUND

• van Dam L, Han SN, Dierickx D, Amant F. Optimal staging of lymphoma during pregnancy is crucial. Womens Health (Lond). 2015 Mar;11(2):101-2. doi: 10.2217/whe.14.77. No abstract available.

  PMID: 25776282 BACKGROUND

• Han SN, Van Peer S, Peccatori F, Gziri MM, Amant F; International Network on Cancer, Infertility and Pregnancy. Contraception is as important as fertility preservation in young women with cancer. Lancet. 2015 Feb 7;385(9967):508. doi: 10.1016/S0140-6736(15)60201-X. No abstract available.

  PMID: 25705843 BACKGROUND

• Han SN, Verheecke M, Vandenbroucke T, Gziri MM, Van Calsteren K, Amant F. Management of gynecological cancers during pregnancy. Curr Oncol Rep. 2014 Dec;16(12):415. doi: 10.1007/s11912-014-0415-z.

  PMID: 25344340 BACKGROUND

• Van Calsteren K, Amant F. Cancer during pregnancy. Acta Obstet Gynecol Scand. 2014 May;93(5):443-6. doi: 10.1111/aogs.12380.

  PMID: 24628416 BACKGROUND

• Amant F, Halaska MJ, Fumagalli M, Dahl Steffensen K, Lok C, Van Calsteren K, Han SN, Mir O, Fruscio R, Uzan C, Maxwell C, Dekrem J, Strauven G, Mhallem Gziri M, Kesic V, Berveiller P, van den Heuvel F, Ottevanger PB, Vergote I, Lishner M, Morice P, Nulman I; ESGO task force 'Cancer in Pregnancy'. Gynecologic cancers in pregnancy: guidelines of a second international consensus meeting. Int J Gynecol Cancer. 2014 Mar;24(3):394-403. doi: 10.1097/IGC.0000000000000062.

  PMID: 24445819 BACKGROUND

• Vandenbriele C, Dierickx D, Amant F, Delforge M. The treatment of hematologic malignancies in pregnancy. Facts Views Vis Obgyn. 2010;2(2):74-87. No abstract available.

  PMID: 25302102 BACKGROUND

• Deckers S, Amant F. Breast cancer in pregnancy: a literature review. Facts Views Vis Obgyn. 2009;1(2):130-41.

  PMID: 25478078 BACKGROUND

• Gziri MM, Goffin F, Debieve F, Amant F. [Cancer diagnosis during pregnancy: importance of a national and European registration]. Rev Med Liege. 2013 Oct;68(10):527-30. French.

  PMID: 24298727 BACKGROUND

• Han SN, Kesic VI, Van Calsteren K, Petkovic S, Amant F; ESGO 'Cancer in Pregnancy' Task Force. Cancer in pregnancy: a survey of current clinical practice. Eur J Obstet Gynecol Reprod Biol. 2013 Mar;167(1):18-23. doi: 10.1016/j.ejogrb.2012.10.026. Epub 2012 Nov 19.

  PMID: 23182070 BACKGROUND

• Han SN, Gziri MM, Van Calsteren K, Amant F. Is chemotherapy during the first trimester of pregnancy really safe? Int J Cancer. 2013 Apr 1;132(7):1728. doi: 10.1002/ijc.27815. Epub 2012 Sep 28. No abstract available.

  PMID: 22945483 BACKGROUND

• Han SN, Lotgerink A, Gziri MM, Van Calsteren K, Hanssens M, Amant F. Physiologic variations of serum tumor markers in gynecological malignancies during pregnancy: a systematic review. BMC Med. 2012 Aug 8;10:86. doi: 10.1186/1741-7015-10-86.

  PMID: 22873292 BACKGROUND

• Loibl S, Han SN, Amant F. Being Pregnant and Diagnosed with Breast Cancer. Breast Care (Basel). 2012 Jun;7(3):204-209. doi: 10.1159/000339674. Epub 2012 Jun 27.

  PMID: 22872793 BACKGROUND

• Amant F. Safety of chemotherapy in pregnancy. Clin Adv Hematol Oncol. 2012 Apr;10(4):258-9. No abstract available.

  PMID: 22706488 BACKGROUND

• Verheecke M, Hermans E, Tuyaerts S, Souche E, Van Bree R, Verbist G, Everaert T, Cortes-Calabuig A, Van Houdt J, Van Calsteren K, Amant F. Acute Drug Effects on the Human Placental Tissue: The Development of a Placental Murine Xenograft Model. Reprod Sci. 2018 Dec;25(12):1637-1648. doi: 10.1177/1933719118756771. Epub 2018 Feb 13.

  PMID: 29439620 BACKGROUND

• Boere I, Lok C, Vandenbroucke T, Amant F. Cancer in pregnancy: safety and efficacy of systemic therapies. Curr Opin Oncol. 2017 Sep;29(5):328-334. doi: 10.1097/CCO.0000000000000386.

  PMID: 28614135 BACKGROUND

• Fruscio R, de Haan J, Van Calsteren K, Verheecke M, Mhallem M, Amant F. Ovarian cancer in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2017 May;41:108-117. doi: 10.1016/j.bpobgyn.2016.09.013. Epub 2016 Oct 1.

  PMID: 28029502 BACKGROUND

• Vercruysse DC, Deprez S, Sunaert S, Van Calsteren K, Amant F. Effects of prenatal exposure to cancer treatment on neurocognitive development, a review. Neurotoxicology. 2016 May;54:11-21. doi: 10.1016/j.neuro.2016.02.013. Epub 2016 Mar 4.

  PMID: 26952827 BACKGROUND

• de Haan J, Vandecaveye V, Han SN, Van de Vijver KK, Amant F. Difficulties with diagnosis of malignancies in pregnancy. Best Pract Res Clin Obstet Gynaecol. 2016 May;33:19-32. doi: 10.1016/j.bpobgyn.2015.10.005. Epub 2015 Oct 19.

  PMID: 26586541 BACKGROUND

• Han SN, Mhallem Gziri M, Van Calsteren K, Amant F. Cervical cancer in pregnant women: treat, wait or interrupt? Assessment of current clinical guidelines, innovations and controversies. Ther Adv Med Oncol. 2013 Jul;5(4):211-9. doi: 10.1177/1758834013494988.

  PMID: 23858330 BACKGROUND

• Amant F, Han SN, Gziri MM, Dekrem J, Van Calsteren K. Chemotherapy during pregnancy. Curr Opin Oncol. 2012 Sep;24(5):580-6. doi: 10.1097/CCO.0b013e328354e754.

  PMID: 22581358 BACKGROUND

• Amant F, Loibl S, Neven P, Van Calsteren K. Breast cancer in pregnancy. Lancet. 2012 Feb 11;379(9815):570-9. doi: 10.1016/S0140-6736(11)61092-1.

  PMID: 22325662 BACKGROUND

• Han SN, Van Calsteren K, Amant F. Use of chemotherapy during pregnancy in the treatment of ovarian malignancies. Eur J Obstet Gynecol Reprod Biol. 2011 Jun;156(2):237. doi: 10.1016/j.ejogrb.2011.02.004. Epub 2011 Mar 25. No abstract available.

  PMID: 21439708 BACKGROUND

• Amant F, Deckers S, Van Calsteren K, Loibl S, Halaska M, Brepoels L, Beijnen J, Cardoso F, Gentilini O, Lagae L, Mir O, Neven P, Ottevanger N, Pans S, Peccatori F, Rouzier R, Senn HJ, Struikmans H, Christiaens MR, Cameron D, Du Bois A. Breast cancer in pregnancy: recommendations of an international consensus meeting. Eur J Cancer. 2010 Dec;46(18):3158-68. doi: 10.1016/j.ejca.2010.09.010.

  PMID: 20932740 BACKGROUND

• Amant F, Brepoels L, Halaska MJ, Gziri MM, Calsteren KV. Gynaecologic cancer complicating pregnancy: an overview. Best Pract Res Clin Obstet Gynaecol. 2010 Feb;24(1):61-79. doi: 10.1016/j.bpobgyn.2009.08.001. Epub 2009 Sep 8.

  PMID: 19740709 BACKGROUND

• Van Calsteren K, Hartmann D, Van Aerschot L, Verbesselt R, Van Bree R, D'Hooge R, Amant F. Vinblastine and doxorubicin administration to pregnant mice affects brain development and behaviour in the offspring. Neurotoxicology. 2009 Jul;30(4):647-57. doi: 10.1016/j.neuro.2009.04.009. Epub 2009 May 5.

  PMID: 19422850 BACKGROUND

• Amant F, Van Calsteren K, Halaska MJ, Beijnen J, Lagae L, Hanssens M, Heyns L, Lannoo L, Ottevanger NP, Vanden Bogaert W, Ungar L, Vergote I, du Bois A. Gynecologic cancers in pregnancy: guidelines of an international consensus meeting. Int J Gynecol Cancer. 2009 May;19 Suppl 1:S1-12. doi: 10.1111/IGC.0b013e3181a1d0ec.

  PMID: 19509538 BACKGROUND

• Van Calsteren K, Devlieger R, De Catte L, D'Hooghe T, Chai DC, Mwenda JM, Vergote I, Amant F. Feasibility of ultrasound-guided percutaneous samplings in the pregnant baboon: a model for studies on transplacental transport. Reprod Sci. 2009 Mar;16(3):280-5. doi: 10.1177/1933719108324890. Epub 2008 Dec 15.

  PMID: 19087981 BACKGROUND

• Amant F, Van Calsteren K, Vergote I, Ottevanger N. Gynecologic oncology in pregnancy. Crit Rev Oncol Hematol. 2008 Sep;67(3):187-95. doi: 10.1016/j.critrevonc.2008.01.006. Epub 2008 Mar 4.

  PMID: 18296060 BACKGROUND

• Van Calsteren K, Heyns L, De Smet F, Van Eycken L, Gziri MM, Van Gemert W, Halaska M, Vergote I, Ottevanger N, Amant F. Cancer during pregnancy: an analysis of 215 patients emphasizing the obstetrical and the neonatal outcomes. J Clin Oncol. 2010 Feb 1;28(4):683-9. doi: 10.1200/JCO.2009.23.2801. Epub 2009 Oct 19.

  PMID: 19841323 RESULT

• Amant F, Van Calsteren K, Halaska MJ, Gziri MM, Hui W, Lagae L, Willemsen MA, Kapusta L, Van Calster B, Wouters H, Heyns L, Han SN, Tomek V, Mertens L, Ottevanger PB. Long-term cognitive and cardiac outcomes after prenatal exposure to chemotherapy in children aged 18 months or older: an observational study. Lancet Oncol. 2012 Mar;13(3):256-64. doi: 10.1016/S1470-2045(11)70363-1. Epub 2012 Feb 10.

  PMID: 22326925 RESULT

• Gziri MM, Debieve F, DE Catte L, Mertens L, Barrea C, VAN Calsteren K, Han SN, Heyns L, Amant F. Chemotherapy during pregnancy: effect of anthracyclines on fetal and maternal cardiac function. Acta Obstet Gynecol Scand. 2012 Dec;91(12):1465-8. doi: 10.1111/j.1600-0412.2012.01524.x. Epub 2012 Nov 1.

  PMID: 22880883 RESULT

• Loibl S, Han SN, von Minckwitz G, Bontenbal M, Ring A, Giermek J, Fehm T, Van Calsteren K, Linn SC, Schlehe B, Gziri MM, Westenend PJ, Muller V, Heyns L, Rack B, Van Calster B, Harbeck N, Lenhard M, Halaska MJ, Kaufmann M, Nekljudova V, Amant F. Treatment of breast cancer during pregnancy: an observational study. Lancet Oncol. 2012 Sep;13(9):887-96. doi: 10.1016/S1470-2045(12)70261-9. Epub 2012 Aug 16.

  PMID: 22902483 RESULT

• Gziri MM, Amant F, Debieve F, Van Calsteren K, De Catte L, Mertens L. Effects of chemotherapy during pregnancy on the maternal and fetal heart. Prenat Diagn. 2012 Jul;32(7):614-9. doi: 10.1002/pd.3847. Epub 2012 Apr 17.

  PMID: 22508540 RESULT

• Mhallem Gziri M, Han SN, Van Calsteren K, Heyns L, Delaere P, Nuyts S, Van den Heuvel F, Cheron AC, Fossion E, Van den Weyngaert D, Lok C, Amant F. Tongue cancers during pregnancy: Case reports and review of literature. Head Neck. 2013 Apr;35(4):E102-8. doi: 10.1002/hed.21924. Epub 2011 Oct 19.

  PMID: 22009853 RESULT

• Gziri MM, Hui W, Amant F, Van Calsteren K, Ottevanger N, Kapusta L, Mertens L. Myocardial function in children after fetal chemotherapy exposure. A tissue Doppler and myocardial deformation imaging study. Eur J Pediatr. 2013 Feb;172(2):163-70. doi: 10.1007/s00431-012-1849-7. Epub 2012 Oct 5.

  PMID: 23052619 RESULT

• Boussios S, Han SN, Fruscio R, Halaska MJ, Ottevanger PB, Peccatori FA, Koubkova L, Pavlidis N, Amant F. Lung cancer in pregnancy: report of nine cases from an international collaborative study. Lung Cancer. 2013 Dec;82(3):499-505. doi: 10.1016/j.lungcan.2013.09.002. Epub 2013 Sep 12.

  PMID: 24091171 RESULT

• Amant F, von Minckwitz G, Han SN, Bontenbal M, Ring AE, Giermek J, Wildiers H, Fehm T, Linn SC, Schlehe B, Neven P, Westenend PJ, Muller V, Van Calsteren K, Rack B, Nekljudova V, Harbeck N, Untch M, Witteveen PO, Schwedler K, Thomssen C, Van Calster B, Loibl S. Prognosis of women with primary breast cancer diagnosed during pregnancy: results from an international collaborative study. J Clin Oncol. 2013 Jul 10;31(20):2532-9. doi: 10.1200/JCO.2012.45.6335. Epub 2013 Apr 22.

  PMID: 23610117 RESULT

• Verheecke M, Halaska MJ, Lok CA, Ottevanger PB, Fruscio R, Dahl-Steffensen K, Kolawa W, Gziri MM, Han SN, Van Calsteren K, Van den Heuvel F, De Vleeschouwer S, Clement PM, Menten J, Amant F; ESGO Task Force 'Cancer in Pregnancy'. Primary brain tumours, meningiomas and brain metastases in pregnancy: report on 27 cases and review of literature. Eur J Cancer. 2014 May;50(8):1462-71. doi: 10.1016/j.ejca.2014.02.018. Epub 2014 Mar 14.

  PMID: 24636876 RESULT

• Vandenbroucke T, Van Calsteren K, Amant F. Pediatric Outcome after Maternal Cancer Diagnosed during Pregnancy. N Engl J Med. 2016 Feb 18;374(7):693. doi: 10.1056/NEJMc1515462. No abstract available.

  PMID: 26886537 RESULT

• Amant F, Vandenbroucke T, Verheecke M, Fumagalli M, Halaska MJ, Boere I, Han S, Gziri MM, Peccatori F, Rob L, Lok C, Witteveen P, Voigt JU, Naulaers G, Vallaeys L, Van den Heuvel F, Lagae L, Mertens L, Claes L, Van Calsteren K; International Network on Cancer, Infertility, and Pregnancy (INCIP). Pediatric Outcome after Maternal Cancer Diagnosed during Pregnancy. N Engl J Med. 2015 Nov 5;373(19):1824-34. doi: 10.1056/NEJMoa1508913. Epub 2015 Sep 28.

  PMID: 26415085 RESULT

• Loibl S, Schmidt A, Gentilini O, Kaufman B, Kuhl C, Denkert C, von Minckwitz G, Parokonnaya A, Stensheim H, Thomssen C, van Calsteren K, Poortmans P, Berveiller P, Markert UR, Amant F. Breast Cancer Diagnosed During Pregnancy: Adapting Recent Advances in Breast Cancer Care for Pregnant Patients. JAMA Oncol. 2015 Nov;1(8):1145-53. doi: 10.1001/jamaoncol.2015.2413.

  PMID: 26247818 RESULT

• Vandenbroucke T, Amant F. Development of children born to mothers with cancer during pregnancy: comparing in utero chemotherapy-exposed children with nonexposed controls. Am J Obstet Gynecol. 2015 Jun;212(6):830-1. doi: 10.1016/j.ajog.2015.01.035. Epub 2015 Jan 28. No abstract available.

  PMID: 25637847 RESULT

• Vandenbroucke T, Verheecke M, Van Calsteren K, Han S, Claes L, Amant F. Fetal outcome after prenatal exposure to chemotherapy and mechanisms of teratogenicity compared to alcohol and smoking. Expert Opin Drug Saf. 2014 Dec;13(12):1653-65. doi: 10.1517/14740338.2014.965677. Epub 2014 Nov 10.

  PMID: 25382454 RESULT

• van Hasselt JGC, van Calsteren K, Heyns L, Han S, Mhallem Gziri M, Schellens JHM, Beijnen JH, Huitema ADR, Amant F. Optimizing anticancer drug treatment in pregnant cancer patients: pharmacokinetic analysis of gestation-induced changes for doxorubicin, epirubicin, docetaxel and paclitaxel. Ann Oncol. 2014 Oct;25(10):2059-2065. doi: 10.1093/annonc/mdu140. Epub 2014 Apr 8.

  PMID: 24713311 RESULT

• Dekrem J, Van Calsteren K, Amant F. Effects of fetal exposure to maternal chemotherapy. Paediatr Drugs. 2013 Oct;15(5):329-34. doi: 10.1007/s40272-013-0040-6.

  PMID: 23856754 RESULT

• Gziri MM, Pokreisz P, De Vos R, Verbeken E, Debieve F, Mertens L, Janssens SP, Amant F. Fetal rat hearts do not display acute cardiotoxicity in response to maternal Doxorubicin treatment. J Pharmacol Exp Ther. 2013 Sep;346(3):362-9. doi: 10.1124/jpet.113.205419. Epub 2013 Jun 21.

  PMID: 23792410 RESULT

• de Haan J, Verheecke M, Van Calsteren K, Van Calster B, Shmakov RG, Mhallem Gziri M, Halaska MJ, Fruscio R, Lok CAR, Boere IA, Zola P, Ottevanger PB, de Groot CJM, Peccatori FA, Dahl Steffensen K, Cardonick EH, Polushkina E, Rob L, Ceppi L, Sukhikh GT, Han SN, Amant F; International Network on Cancer and Infertility Pregnancy (INCIP). Oncological management and obstetric and neonatal outcomes for women diagnosed with cancer during pregnancy: a 20-year international cohort study of 1170 patients. Lancet Oncol. 2018 Mar;19(3):337-346. doi: 10.1016/S1470-2045(18)30059-7. Epub 2018 Jan 26.

  PMID: 29395867 RESULT

• de Haan J, van Thienen JV, Casaer M, Hannivoort RA, Van Calsteren K, van Tuyl M, van Gerwen MM, Debeer A, Amant F, Painter RC. Severe Adverse Reaction to Vemurafenib in a Pregnant Woman with Metastatic Melanoma. Case Rep Oncol. 2018 Feb 15;11(1):119-124. doi: 10.1159/000487128. eCollection 2018 Jan-Apr.

  PMID: 29606950 RESULT

• Boucek J, de Haan J, Halaska MJ, Plzak J, Van Calsteren K, de Groot CJM, Dahl Steffensen K, Fruscio R, Massolt ET, Klaritsch P, Zola P, Amant F; International Network on Cancer, Infertility, and Pregnancy. Maternal and obstetrical outcome in 35 cases of well-differentiated thyroid carcinoma during pregnancy. Laryngoscope. 2018 Jun;128(6):1493-1500. doi: 10.1002/lary.26936. Epub 2017 Oct 8.

  PMID: 28988434 RESULT

• de Haan J, Lok CA, de Groot CJ, Crijns MB, Van Calsteren K, Dahl Steffensen K, Halaska MJ, Altintas S, Boere IA, Fruscio R, Kolawa W, Witteveen PO, Amant F; International Network on Cancer, Infertility and Pregnancy (INCIP). Melanoma during pregnancy: a report of 60 pregnancies complicated by melanoma. Melanoma Res. 2017 Jun;27(3):218-223. doi: 10.1097/CMR.0000000000000327.

  PMID: 28099365 RESULT

• Verheecke M, Cortes Calabuig A, Finalet Ferreiro J, Brys V, Van Bree R, Verbist G, Everaert T, Leemans L, Gziri MM, Boere I, Halaska MJ, Vanhoudt J, Amant F, Van Calsteren K. Genetic and microscopic assessment of the human chemotherapy-exposed placenta reveals possible pathways contributive to fetal growth restriction. Placenta. 2018 Apr;64:61-70. doi: 10.1016/j.placenta.2018.03.002. Epub 2018 Mar 9.

  PMID: 29626982 RESULT

• Vandenbroucke T, Verheecke M, Fumagalli M, Lok C, Amant F. Effects of cancer treatment during pregnancy on fetal and child development. Lancet Child Adolesc Health. 2017 Dec;1(4):302-310. doi: 10.1016/S2352-4642(17)30091-3. Epub 2017 Sep 29.

  PMID: 30169185 RESULT

• Gziri MM, Brunee L, Cayphas C, Prigogine T, Van Raemdonck D, Amant F, Hubinont C. Low-grade bronchial mucoepidermoid carcinoma during pregnancy successfully treated by lobectomy. J Obstet Gynaecol. 2017 Nov;37(8):1082-1084. doi: 10.1080/01443615.2017.1308325. Epub 2017 Jun 1. No abstract available.

  PMID: 28569562 RESULT

• de Haan J, Van Calsteren K, Lok CAR, de Groot CJM, Amant F. Comment on "Maternal and perinatal outcomes in pregnancy-associated melanoma. Report of two cases and a systematic literature review". Eur J Obstet Gynecol Reprod Biol. 2017 Sep;216:261-262. doi: 10.1016/j.ejogrb.2017.07.025. Epub 2017 Jul 23. No abstract available.

  PMID: 28768572 RESULT

• Vandenbroucke T, Han SN, Van Calsteren K, Wilderjans TF, Van den Bergh BRH, Claes L, Amant F. Psychological distress and cognitive coping in pregnant women diagnosed with cancer and their partners. Psychooncology. 2017 Aug;26(8):1215-1221. doi: 10.1002/pon.4301. Epub 2016 Nov 21.

  PMID: 27859911 RESULT

• Gziri MM, Han SN, Amant F. Use of general anesthesia and sentinel node procedure during pregnancy. J Surg Oncol. 2012 Dec;106(8):1008. doi: 10.1002/jso.23164. Epub 2012 Jun 4. No abstract available.

  PMID: 22674350 RESULT

• Lambrechts S, Van Calsteren K, Capoen A, Op De Beeck K, Joniau S, Timmerman D, Amant F. Polypoid endometriosis of the bladder during pregnancy mimicking urachal carcinoma. Ultrasound Obstet Gynecol. 2011 Oct;38(4):475-8. doi: 10.1002/uog.8985. Epub 2011 Sep 6.

  PMID: 21374752 RESULT

• Van Calsteren K, Verbesselt R, Van Bree R, Heyns L, de Bruijn E, de Hoon J, Amant F. Substantial variation in transplacental transfer of chemotherapeutic agents in a mouse model. Reprod Sci. 2011 Jan;18(1):57-63. doi: 10.1177/1933719110379650. Epub 2010 Sep 8.

  PMID: 20826505 RESULT

• Van Calsteren K, Verbesselt R, Beijnen J, Devlieger R, De Catte L, Chai DC, Van Bree R, Heyns L, de Hoon J, Amant F. Transplacental transfer of anthracyclines, vinblastine, and 4-hydroxy-cyclophosphamide in a baboon model. Gynecol Oncol. 2010 Dec;119(3):594-600. doi: 10.1016/j.ygyno.2010.08.019. Epub 2010 Sep 17.

  PMID: 20846713 RESULT

• Calsteren KV, Verbesselt R, Devlieger R, De Catte L, Chai DC, Van Bree R, Heyns L, Beijnen J, Demarsin S, de Bruijn E, de Hoon J, Amant F. Transplacental transfer of paclitaxel, docetaxel, carboplatin, and trastuzumab in a baboon model. Int J Gynecol Cancer. 2010 Dec;20(9):1456-64. doi: 10.1111/IGC.0b013e3181fb18c8.

  PMID: 21307819 RESULT

• Van Calsteren K, Verbesselt R, Ottevanger N, Halaska M, Heyns L, Van Bree R, de Bruijn E, Chai D, Delforge M, Noens L, Renard V, Witteveen E, Rob L, de Hoon J, Amant F. Pharmacokinetics of chemotherapeutic agents in pregnancy: a preclinical and clinical study. Acta Obstet Gynecol Scand. 2010 Oct;89(10):1338-45. doi: 10.3109/00016349.2010.512070.

  PMID: 20846067 RESULT

• Van Calsteren K, Hanssens M, Moerman P, Orye G, Bielen D, Vergote I, Amant F. Successful conservative treatment of endocervical adenocarcinoma stage Ib1 diagnosed early in pregnancy. Acta Obstet Gynecol Scand. 2008;87(2):250-3. doi: 10.1080/00016340701870794.

  PMID: 18231896 RESULT

• Van Calsteren K, Van Mensel K, Joniau S, Oyen R, Hanssens M, Amant F, Van Poppel H. Urachal carcinoma during pregnancy. Urology. 2006 Jun;67(6):1290.e19-21. doi: 10.1016/j.urology.2005.12.041.

  PMID: 16750250 RESULT

• Kruse AM, Huis In 't Veld EA, van Grotel M, Amant F, van Tinteren H, van den Heuvel-Eibrink MM, Verwaaijen EJ. Motor development in toddlers prenatally exposed to maternal cancer treatment: a national cohort study in the Netherlands. EClinicalMedicine. 2026 Jan 17;92:103738. doi: 10.1016/j.eclinm.2025.103738. eCollection 2026 Feb.

  PMID: 41623857 DERIVED

• Van Assche IA, Van Calsteren K, Huis In 't Veld EA, van Gerwen M, Heylen L, LeJeune CL, Cardonick E, Halaska MJ, Fruscio R, Fumagalli M, van Dijk-Lokkart EM, Lemiere J, van Grotel M, Lagae L, van den Heuvel-Eibrink MM, Amant F. Child outcomes after prenatal exposure to platinum and taxane-based chemotherapy: an unplanned interim analysis of the international network on cancer, infertility, and pregnancy study. EClinicalMedicine. 2024 Nov 11;78:102922. doi: 10.1016/j.eclinm.2024.102922. eCollection 2024 Dec.

  PMID: 39588212 DERIVED

• Vandenbroucke T, Verheecke M, van Gerwen M, Van Calsteren K, Halaska MJ, Fumagalli M, Fruscio R, Gandhi A, Veening M, Lagae L, Ottevanger PB, Voigt JU, de Haan J, Gziri MM, Maggen C, Mertens L, Naulaers G, Claes L, Amant F; International Network on Cancer, Infertility and Pregnancy (INCIP). Child development at 6 years after maternal cancer diagnosis and treatment during pregnancy. Eur J Cancer. 2020 Oct;138:57-67. doi: 10.1016/j.ejca.2020.07.004. Epub 2020 Aug 25.

  PMID: 32858478 DERIVED

Related Links

• This site provides background information on the problem of cancer in pregnancy and details further the project.

Biospecimen

Retention: SAMPLES WITH DNA

Maternal blood serum and sediment of blood; from 2010 on we collect umbilical cord blood. Since new approval of protocol version 4.2 (08-02-2018) we collect samples of placental tissue, umbilical cord tissue and membranes.

MeSH Terms

Conditions

Neoplasms

Study Officials

• Amant Frederic, MD PhD

  KULeuven, Belgium

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ayaka Wakatsuki

CONTACT

+32 16 34 41 69; ayaka.wakatsuki@uzleuven.be

Kristel Van Calsteren, MD PhD

CONTACT

+32-16-346192; kristel.vancalsteren@uzleuven.be

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 18 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 25, 2006
• First Posted: May 26, 2006
• Study Start: August 1, 2005
• Primary Completion: April 1, 2025
• Study Completion (Estimated): December 1, 2032
• Last Updated: March 6, 2024

Record last verified: 2024-03

Locations

AR (1); PL (3); AU (1); GR (4); IT (5); NO (1); SE (1); DK (1); FR (1); TU (1); CZ (2); PT (1); RU (3); BE (2); ME (1); US (1); NL (1); DE (1); UA (1)