Molecular Markers in Treatment in Endometrial Cancer

NCT00598845 | Unknown

• 3 other identifiers: NSD 15501REK 96/1478-2Helse Vest 911351
• Study Type: observational
• Target: 1,000
• Locations: 3 countries
• Sites: 9

Brief Summary

The purpose of this prospective multicenter trial is to investigate the value of molecular markers in endometrial cancer for predicting lymph node metastasis and prognosis in relation to treatment.

Conditions

Endometrial Neoplasms; Neoplasm Metastasis

Keywords

Endometrial cancer; Molecular markers; Lymph node metastasis; Prospective study; Prognosis; Cancer of Endometrium; Tumor Markers, Biological

Outcome Measures

Primary Outcomes (1)

• Presence of lymph node metastases

  At primary treatment

Secondary Outcomes (1)

• Recurrent disease, death from disease

  5 years after primary treatment

Study Arms (1)

Consecutive numbers

Patients with endometrial cancer

Procedure: Tumor biopsy study

Interventions

Tumor biopsy study PROCEDURE

Tumor specimens from endometrial cancer patients, collected preoperatively and during primary hysterectomy, are investigated.

Consecutive numbers

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women with endometrial carcinoma that undergo an endometrial biopsy before treatment with hysterectomy with bilateral salpingoophorectomy with or without pelvic lymph node staging.

You may qualify if:

• Women with endometrial carcinoma
• Available endometrial biopsy
• Informed consent

You may not qualify if:

• No informed consent

Sponsors & Collaborators

• University of Bergen: lead
• Helse-Bergen HF: collaborator
• Norwegian Cancer Society: collaborator

Study Sites (9)

Gynecological Oncology, UZ Gasthuisberg

Leuven, 3000, Belgium

RECRUITING

Department of Gynecology, Ålesund Hospital

Ålesund, Norway

RECRUITING

Sentralsykehuset i Førde

Førde, N6807, Norway

RECRUITING

Helse-Fonna, Haugesund Sjukehus

Haugesund, N5528, Norway

RECRUITING

Kvinneklinikken, Akershus Universitetssykehus

Lørenskog, N1478, Norway

RECRUITING

Kvinnesenteret, Ullevål Universitetssykehus

Oslo, N0450, Norway

RECRUITING

Department of Gynecology, St Olav's Hospital

Trondheim, N7006, Norway

RECRUITING

Sykehuset Vestfold HF

Tønsberg, N3103, Norway

RECRUITING

Senter for Surgical Gynecologic Oncology, Sahlgrenska University Hospital

Gothenburg, SE-41345, Sweden

RECRUITING

Related Publications (10)

• Engelsen IB, Stefansson I, Akslen LA, Salvesen HB. Pathologic expression of p53 or p16 in preoperative curettage specimens identifies high-risk endometrial carcinomas. Am J Obstet Gynecol. 2006 Oct;195(4):979-86. doi: 10.1016/j.ajog.2006.02.045. Epub 2006 May 3.

  PMID: 16677592 BACKGROUND

• Stefansson IM, Salvesen HB, Akslen LA. Vascular proliferation is important for clinical progress of endometrial cancer. Cancer Res. 2006 Mar 15;66(6):3303-9. doi: 10.1158/0008-5472.CAN-05-1163.

  PMID: 16540684 BACKGROUND

• Bachmann IM, Halvorsen OJ, Collett K, Stefansson IM, Straume O, Haukaas SA, Salvesen HB, Otte AP, Akslen LA. EZH2 expression is associated with high proliferation rate and aggressive tumor subgroups in cutaneous melanoma and cancers of the endometrium, prostate, and breast. J Clin Oncol. 2006 Jan 10;24(2):268-73. doi: 10.1200/JCO.2005.01.5180. Epub 2005 Dec 5.

  PMID: 16330673 BACKGROUND

• Stefansson IM, Salvesen HB, Akslen LA. Prognostic impact of alterations in P-cadherin expression and related cell adhesion markers in endometrial cancer. J Clin Oncol. 2004 Apr 1;22(7):1242-52. doi: 10.1200/JCO.2004.09.034.

  PMID: 15051772 BACKGROUND

• Straume O, Chappuis PO, Salvesen HB, Halvorsen OJ, Haukaas SA, Goffin JR, Begin LR, Foulkes WD, Akslen LA. Prognostic importance of glomeruloid microvascular proliferation indicates an aggressive angiogenic phenotype in human cancers. Cancer Res. 2002 Dec 1;62(23):6808-11.

  PMID: 12460889 BACKGROUND

• Salvesen HB, Iversen OE, Akslen LA. Prognostic significance of angiogenesis and Ki-67, p53, and p21 expression: a population-based endometrial carcinoma study. J Clin Oncol. 1999 May;17(5):1382-90. doi: 10.1200/JCO.1999.17.5.1382.

  PMID: 10334522 BACKGROUND

• Wik E, Trovik J, Iversen OE, Engelsen IB, Stefansson IM, Vestrheim LC, Haugland HK, Akslen LA, Salvesen HB. Deoxyribonucleic acid ploidy in endometrial carcinoma: a reproducible and valid prognostic marker in a routine diagnostic setting. Am J Obstet Gynecol. 2009 Dec;201(6):603.e1-7. doi: 10.1016/j.ajog.2009.07.029. Epub 2009 Oct 3.

  PMID: 19800606 BACKGROUND

• Salvesen HB, Carter SL, Mannelqvist M, Dutt A, Getz G, Stefansson IM, Raeder MB, Sos ML, Engelsen IB, Trovik J, Wik E, Greulich H, Bo TH, Jonassen I, Thomas RK, Zander T, Garraway LA, Oyan AM, Sellers WR, Kalland KH, Meyerson M, Akslen LA, Beroukhim R. Integrated genomic profiling of endometrial carcinoma associates aggressive tumors with indicators of PI3 kinase activation. Proc Natl Acad Sci U S A. 2009 Mar 24;106(12):4834-9. doi: 10.1073/pnas.0806514106. Epub 2009 Mar 4.

  PMID: 19261849 BACKGROUND

• Dutt A, Salvesen HB, Chen TH, Ramos AH, Onofrio RC, Hatton C, Nicoletti R, Winckler W, Grewal R, Hanna M, Wyhs N, Ziaugra L, Richter DJ, Trovik J, Engelsen IB, Stefansson IM, Fennell T, Cibulskis K, Zody MC, Akslen LA, Gabriel S, Wong KK, Sellers WR, Meyerson M, Greulich H. Drug-sensitive FGFR2 mutations in endometrial carcinoma. Proc Natl Acad Sci U S A. 2008 Jun 24;105(25):8713-7. doi: 10.1073/pnas.0803379105. Epub 2008 Jun 13.

  PMID: 18552176 BACKGROUND

• Trovik J, Wik E, Werner HM, Krakstad C, Helland H, Vandenput I, Njolstad TS, Stefansson IM, Marcickiewicz J, Tingulstad S, Staff AC; MoMaTEC study group; Amant F, Akslen LA, Salvesen HB. Hormone receptor loss in endometrial carcinoma curettage predicts lymph node metastasis and poor outcome in prospective multicentre trial. Eur J Cancer. 2013 Nov;49(16):3431-41. doi: 10.1016/j.ejca.2013.06.016. Epub 2013 Aug 8.

  PMID: 23932335 DERIVED

Related Links

• Nordic Society of Gynecologic Oncology

Biospecimen

Retention: SAMPLES WITH DNA

Tumor specimens from endometrial carcinoma, from curettage and hysterectomy specimens, formalin-fixed and paraffin-embedded and fresh frozen, stored at minus 80 °C, corresponding blood samples with normal DNA

MeSH Terms

Conditions

Endometrial Neoplasms; Neoplasm Metastasis; Lymphatic Metastasis

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Helga B. Salvesen, Prof., MD, PhD

  University of Bergen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Britt Edvardsen, AVD ING

CONTACT

+4755974200; britt.edvardsen@helse-bergen.no

Ingjerd Bergo, Tech

CONTACT

+4755974200; ingjerd.bergo@helse-bergen.no

Study Design

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

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 23, 2008
• Study Start: April 1, 2001
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2017
• Last Updated: December 23, 2014

Record last verified: 2014-12

Locations

BE (1); NO (7); SE (1)