Perinatal Thoraco-abdomino-pelvic Tumors Study

NCT06365268 | Completed

• 1 other identifier: APHP231139
• Study Type: observational
• Target: 152
• Locations: 1 country
• Sites: 5

Brief Summary

Congenital tumors are a rare diagnosis in the fetus and newborn. They differ from those of children and adults in terms of the nature, location and evolution of the tumor. Indeed, some histologically benign tumors may have lethal potential in utero (e.g. sacrococcygeal teratomas) or even undergo malignant transformation if left untreated. In contrast, other tumors that are malignant by histological criteria may have a very good prognosis, regressing spontaneously within the first year of life (e.g. neuroblastoma). Despite advances in imaging, benign and malignant solid tumors remain a major diagnostic and prognostic challenge in the antenatal context. The management of congenital tumors requires multidisciplinary expertise, taking into account the perinatal context, which poses specific problems, particularly in terms of therapeutic aspects, but also the frequent existence of associated malformations and/or genetic predisposition syndromes. This study focuses on solid tumors of the thoraco-abdomino-pelvic region, the main objective being to investigate the correlation between antenatal clinical and radiological analysis and confirmed postnatal diagnosis of congenital solid truncal tumors, as well as the developmental spectrum in which they fit.

Conditions

Perinatal Solid Tumors of the Thoraco-abdomino-pelvic Region

Keywords

Congenital truncal tumors; Antenatal diagnosis

Outcome Measures

Primary Outcomes (2)

• Correlation between antenatal clinico-radiological analysis and postnatal diagnosis of solid congenital truncal tumors

  Study of data from the patient's medical file.

  3 years

• Description of the developmental spectrum of solid congenital truncal tumors

  Study of data from the patient's medical file.

  3 years

Secondary Outcomes (6)

• Characteristics and location of the tumor on pre- and post-natal imaging

  3 years

• Ile-de-France epidemiology of perinatal tumors

  Through study completion, an average of 4 months

• Evolution of solid congenital truncal tumors

  Through study completion, an average of 4 months

• Associated genetic abnormalities and malformations

  Through study completion, an average of 4 months

• Intercurrent obstetric events and obstetric outcomes based on the diagnoses made

  Through study completion, an average of 4 months

Study Arms (1)

Patients

Mother-child whose care course for the child's congenital axial tumor included treatment at the AP-HP between 2010 and 2021. Fetus presenting a malignant or benign solid tumor of thoracic, abdominal or pelvic location and whose clinico-radiological or histological diagnosis is confirmed postnatally up to 1 year of life with the onset of symptoms in the first three months of life.

Other: Collection of data from the patient's medical file

Interventions

Collection of data from the patient's medical file OTHER

Collection of data from the patient's medical file. The data collected concerns a period of three years maximum.

Patients

Eligibility Criteria

• Age: Up to 3 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Mother-child whose care course for the child's congenital axial tumor included treatment at the AP-HP (Assistance Publique - Hôpitaux de Paris) between 2010 and 2021. Fetus presenting a malignant or benign solid tumor of thoracic, abdominal or pelvic location and whose clinico-radiological or histological diagnosis is confirmed postnatally up to 1 year of life with the onset of symptoms in the first three months of life.

You may qualify if:

• Information of the holders of parental authority of the patients concerned by the research
• Malignant or benign solid tumor
• Thoracic, abdominal or pelvic location
• Clinico-radiological or histological diagnosis confirmed postnatally up to 1 year of life with onset of symptoms in the first three months of life
• Mother-child whose care course for the child's congenital axial tumor included treatment at the AP-HP

You may not qualify if:

• Opposition from holders of parental authority of patients
• Sacrococcygeal teratomas
• Central nervous system tumors
• Heart tumors
• Ovarian cysts
• Head and neck tumors
• Congenital leukemia and hemopathy

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead
• URC-CIC Paris Descartes Necker Cochin: collaborator

Study Sites (5)

Hôpital Antoine Béclère

Clamart, 92140, France

Location

Hôpital Bicêtre

Le Kremlin-Bicêtre, 94270, France

Location

Hôpital Armand Trousseau

Paris, 75012, France

Location

Hôpital Necker-Enfants Malades

Paris, 75015, France

Location

Hôpital Robert Debré

Paris, 75019, France

Location

Related Publications (14)

• Khawand C, Orbach D, Berrebi D, Branchereau S, Mussini C, Brisse HJ, Grevent D, Jouannic JM, Vivanti A, Minard-Colin V, Ville Y, Sarnacki S; Collaborators. Prenatal diagnosis and postnatal management of perinatal thoracoabdominopelvic tumors: multicenter experience. Ultrasound Obstet Gynecol. 2025 Oct;66(4):499-508. doi: 10.1002/uog.70000. Epub 2025 Aug 23.

  PMID: 40847681 BACKGROUND

• Isaacs H Jr. Perinatal (congenital and neonatal) neoplasms: a report of 110 cases. Pediatr Pathol. 1985;3(2-4):165-216. doi: 10.3109/15513818509078782.

  PMID: 3879355 BACKGROUND

• Moore SW, Satge D, Sasco AJ, Zimmermann A, Plaschkes J. The epidemiology of neonatal tumours. Report of an international working group. Pediatr Surg Int. 2003 Sep;19(7):509-19. doi: 10.1007/s00383-003-1048-8. Epub 2003 Sep 11.

  PMID: 14523568 BACKGROUND

• Geurten C, Geurten M, Rigo V, Dresse MF. Neonatal Cancer Epidemiology and Outcome: A Retrospective Study. J Pediatr Hematol Oncol. 2020 Jul;42(5):e286-e292. doi: 10.1097/MPH.0000000000001692.

  PMID: 31815889 BACKGROUND

• Parkes SE, Muir KR, Southern L, Cameron AH, Darbyshire PJ, Stevens MC. Neonatal tumours: a thirty-year population-based study. Med Pediatr Oncol. 1994;22(5):309-17. doi: 10.1002/mpo.2950220503.

  PMID: 8127254 BACKGROUND

• Alamo L, Beck-Popovic M, Gudinchet F, Meuli R. Congenital tumors: imaging when life just begins. Insights Imaging. 2011 Jun;2(3):297-308. doi: 10.1007/s13244-011-0073-8. Epub 2011 Feb 14.

  PMID: 22347954 BACKGROUND

• Avni FE, Massez A, Cassart M. Tumours of the fetal body: a review. Pediatr Radiol. 2009 Nov;39(11):1147-57. doi: 10.1007/s00247-009-1160-6. Epub 2009 Feb 24.

  PMID: 19238373 BACKGROUND

• Orbach D, Sarnacki S, Brisse HJ, Gauthier-Villars M, Jarreau PH, Tsatsaris V, Baruchel A, Zerah M, Seigneur E, Peuchmaur M, Doz F. Neonatal cancer. Lancet Oncol. 2013 Dec;14(13):e609-20. doi: 10.1016/S1470-2045(13)70236-5.

  PMID: 24275134 BACKGROUND

• Kamil D, Tepelmann J, Berg C, Heep A, Axt-Fliedner R, Gembruch U, Geipel A. Spectrum and outcome of prenatally diagnosed fetal tumors. Ultrasound Obstet Gynecol. 2008 Mar;31(3):296-302. doi: 10.1002/uog.5260.

  PMID: 18307207 BACKGROUND

• Amari F, Beyer DA, Diedrich K, Weichert J. Fetal intra-abdominal tumors: assessment of spectrum, accuracy of prenatal diagnosis, perinatal outcome and therapy at a tertiary referral center. Eur J Obstet Gynecol Reprod Biol. 2013 Apr;167(2):160-6. doi: 10.1016/j.ejogrb.2012.11.023. Epub 2013 Jan 5.

  PMID: 23295072 BACKGROUND

• Meizner I. Perinatal oncology--the role of prenatal ultrasound diagnosis. Ultrasound Obstet Gynecol. 2000 Nov;16(6):507-9. doi: 10.1046/j.1469-0705.2000.00297.x. No abstract available.

  PMID: 11169341 BACKGROUND

• Isaacs H Jr. Fetal hydrops associated with tumors. Am J Perinatol. 2008 Jan;25(1):43-68. doi: 10.1055/s-2007-1004826. Epub 2007 Dec 12.

  PMID: 18075961 BACKGROUND

• Braun T, Brauer M, Fuchs I, Czernik C, Dudenhausen JW, Henrich W, Sarioglu N. Mirror syndrome: a systematic review of fetal associated conditions, maternal presentation and perinatal outcome. Fetal Diagn Ther. 2010;27(4):191-203. doi: 10.1159/000305096. Epub 2010 Mar 27.

  PMID: 20357423 BACKGROUND

• Sauvat F, Sarnacki S, Brisse H, Medioni J, Rubie H, Aigrain Y, Gauthier F, Audry G, Helardot P, Landais P, Michon J, Hartmann O, Nihoul-Fekete C. Outcome of suprarenal localized masses diagnosed during the perinatal period: a retrospective multicenter study. Cancer. 2002 May 1;94(9):2474-80. doi: 10.1002/cncr.10502.

  PMID: 12015773 BACKGROUND

Study Officials

• Sabine SARNACKI, M.D., PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

• Chelsea KHAWAND, M.D.

  Assistance Publique - Hôpitaux de Paris

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2024
• First Posted: April 15, 2024
• Study Start: September 5, 2024
• Primary Completion: October 10, 2024
• Study Completion: October 10, 2024
• Last Updated: September 19, 2025

Record last verified: 2025-09

Locations

FR (5)