MoMaTEC: Molecular Markers in Treatment in Endometrial Cancer

• Sponsor: University of Bergen (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT00598845
• Collaborator: Helse-Bergen HF (Other), Norwegian Cancer Society (Other)
• Enrollment: 1,000
• Locations: 9
• Duration (Months): 200
• Patients Per Site: 111.1
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Endometrial Neoplasms; Neoplasm Metastasis	Procedure: Tumor biopsy study

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Prospective Study of Endometrial Cancer Treatment in Relation to Molecular Markers in Curettage Specimens.
• Study Start Date: Apr 1, 2001
• Anticipated Primary Completion Date: Dec 1, 2015
• Anticipated Study Completion Date: Dec 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Consecutive numbers Patients with endometrial cancer	Procedure: Tumor biopsy study; Tumor specimens from endometrial cancer patients, collected preoperatively and during primary hysterectomy, are investigated.

Outcome Measures

Primary Outcome Measures

1. Presence of lymph node metastases [At primary treatment]

Secondary Outcome Measures

1. Recurrent disease, death from disease [5 years after primary treatment]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Women with endometrial carcinoma

• Available endometrial biopsy

• Informed consent

Exclusion Criteria:

• No informed consent

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gynecological Oncology, UZ Gasthuisberg	Leuven		Belgium	3000
2	Sentralsykehuset i Førde	Førde		Norway	N6807
3	Helse-Fonna, Haugesund Sjukehus	Haugesund		Norway	N5528
4	Kvinneklinikken, Akershus Universitetssykehus	Lørenskog		Norway	N1478
5	Kvinnesenteret, Ullevål Universitetssykehus	Oslo		Norway	N0450
6	Department of Gynecology, St Olav's Hospital	Trondheim		Norway	N7006
7	Sykehuset Vestfold HF	Tønsberg		Norway	N3103
8	Department of Gynecology, Ålesund Hospital	Ålesund		Norway
9	Senter for Surgical Gynecologic Oncology, Sahlgrenska University Hospital	Gothenburg		Sweden	SE-41345

Sponsors and Collaborators

• University of Bergen
• Helse-Bergen HF
• Norwegian Cancer Society

Investigators

• Principal Investigator: Helga B. Salvesen, Prof., MD, PhD, University of Bergen

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Nordic Society of Gynecologic Oncology

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

• Responsible Party: Helga B Salvesen, Professor, MD, PhD, University of Bergen
• ClinicalTrials.gov Identifier: NCT00598845
• Other Study ID Numbers: NSD 15501; NSD 15501; REK 96/1478-2; Helse Vest 911351
• First Posted: Jan 23, 2008
• Last Update Posted: Dec 23, 2014
• Last Verified: Dec 1, 2014

• Keywords provided by Helga B Salvesen, Professor, MD, PhD, University of Bergen: Endometrial cancer; Molecular markers; Lymph node metastasis; Prospective study; Prognosis; Cancer of Endometrium; Tumor Markers, Biological
• Additional relevant MeSH terms: Neoplasms; Neoplasm Metastasis; Endometrial Neoplasms

Study Results

No Results Posted as of Dec 23, 2014