Molecular Markers in Treatment in Endometrial Cancer

Neoplasm Metastasis Clinical Trial

— MoMaTEC  

Official title:

Prospective Study of Endometrial Cancer Treatment in Relation to Molecular Markers in Curettage Specimens.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00598845
• Other study ID #: NSD 15501
• Secondary ID: NSD 15501REK 96/
• Status: Recruiting
• Phase: N/A
• First received: December 26, 2007
• Last updated: December 22, 2014
• Start date: April 2001
• Est. completion date: December 2017

Study information

• Verified date: December 2014
• Source: University of Bergen
• Contact: Britt Edvardsen, AVD ING
• Phone: +4755974200
• Email: britt.edvardsen[@]helse-bergen.no
• Is FDA regulated: No
• Health authority: Norway: Data Protection AuthorityNorway: Directorate of HealthNorway: Norwegian Social Science Data ServicesNorway:National Committee for Medical and Health Research Ethics
• Study type: Observational

Clinical Trial 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.

Description:

This is a prospective multicenter study to investigate the predictive value of molecular markers in endometrial cancer for lymph node metastasis, prognosis and treatment. For the previously studied tumor markers p53, p16, ER, PR and HER2neu, we want to investigate the expression in curettage material in relation to lymph node metastasis and prognosis among endometrial carcinoma patients. We also want to investigate the distribution of genetic alterations in fresh frozen tumor tissue in order to design prospective randomized treatment trials of metastatic endometrial cancer based on molecular profile. There will be a special emphasis on disturbances in the pathways influenced by new targeted therapy, such as inhibitors of Her2/NEU, EGFR, receptor tyrosine kinase, mTOR, PTEN and hormone receptor pathways.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2017
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Women with endometrial carcinoma

• Available endometrial biopsy

• Informed consent

Exclusion Criteria:

• No informed consent

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Neoplasm Metastasis
• Neoplasms

Intervention

Procedure:
• Tumor biopsy study
Tumor specimens from endometrial cancer patients, collected preoperatively and during primary hysterectomy, are investigated.

Locations

Country	Name	City	State
Belgium	Gynecological Oncology, UZ Gasthuisberg	Leuven
Norway	Department of Gynecology, Ålesund Hospital	Ålesund
Norway	Sentralsykehuset i Førde	Førde
Norway	Helse-Fonna, Haugesund Sjukehus	Haugesund
Norway	Kvinneklinikken, Akershus Universitetssykehus	Lørenskog
Norway	Kvinnesenteret, Ullevål Universitetssykehus	Oslo
Norway	Sykehuset Vestfold HF	Tønsberg
Norway	Department of Gynecology, St Olav's Hospital	Trondheim
Sweden	Senter for Surgical Gynecologic Oncology, Sahlgrenska University Hospital	Gothenburg

Sponsors (3)

Lead Sponsor	Collaborator
University of Bergen	Helse-Bergen HF, Norwegian Cancer Society

Countries where clinical trial is conducted

Belgium,  Norway,  Sweden, 

References & Publications (9)

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. Epub 2005 Dec 5. — View Citation

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. — View Citation

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. Epub 2006 May 3. — View Citation

Salvesen HB, Carter SL, Mannelqvist M, Dutt A, Getz G, Stefansson IM, Raeder MB, Sos ML, Engelsen IB, Trovik J, Wik E, Greulich H, Bø 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Straume O, Chappuis PO, Salvesen HB, Halvorsen OJ, Haukaas SA, Goffin JR, Bégin 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of lymph node metastases		At primary treatment	No
Secondary	Recurrent disease, death from disease		5 years after primary treatment	No

External Links

•   Nordic Society of Gynecologic Oncology