Molecular Markers in Treatment in Endometrial Cancer

• Conditions: Endometrial Neoplasms; Neoplasm Metastasis
• Interventions: Procedure: Tumor biopsy study

• Registration Number: NCT00598845
• Lead Sponsor: University of Bergen

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.

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 Timeline

• Study Start: 2001-04
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-01-22
• Study First Posted: 2008-01-23
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-22
• Last Update Posted: 2014-12-23
• Primary Completion: 2015-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 1000

Inclusion Criteria

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

Exclusion Criteria

• No informed consent

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Consecutive numbers	Tumor biopsy study	Patients with endometrial cancer

Primary Outcome Measures

Name	Time	Method
Presence of lymph node metastases	At primary treatment

Secondary Outcome Measures

Name	Time	Method
Recurrent disease, death from disease	5 years after primary treatment

Trial Locations

Locations (9)

Sentralsykehuset i Førde; 🇳🇴 Førde, Norway

Kvinneklinikken, Akershus Universitetssykehus; 🇳🇴 Lørenskog, Norway

Department of Gynecology, St Olav's Hospital; 🇳🇴 Trondheim, Norway

Sykehuset Vestfold HF; 🇳🇴 Tønsberg, Norway

Department of Gynecology, Ålesund Hospital; 🇳🇴 Ålesund, Norway

Gynecological Oncology, UZ Gasthuisberg; 🇧🇪 Leuven, Belgium

Helse-Fonna, Haugesund Sjukehus; 🇳🇴 Haugesund, Norway

Kvinnesenteret, Ullevål Universitetssykehus; 🇳🇴 Oslo, Norway

Senter for Surgical Gynecologic Oncology, Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Sweden