Prospective Study of Endometrial Cancer Treatment in Relation to Molecular Markers in Curettage Specimens.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Endometrial Neoplasms
- Sponsor
- University of Bergen
- Enrollment
- 1000
- Locations
- 9
- Primary Endpoint
- Presence of lymph node metastases
- Last Updated
- 11 years ago
Overview
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.
Investigators
Helga B Salvesen
Professor, MD, PhD
University of Bergen
Eligibility Criteria
Inclusion Criteria
- •Women with endometrial carcinoma
- •Available endometrial biopsy
- •Informed consent
Exclusion Criteria
- •No informed consent
Outcomes
Primary Outcomes
Presence of lymph node metastases
Time Frame: At primary treatment
Secondary Outcomes
- Recurrent disease, death from disease(5 years after primary treatment)