Biomarker Guided Treatment in Gynaecological Cancer

• Status: Recruiting
• Trial end date: 2033-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

MoMaTEC2 aims to test, in clinically oriented studies, the applicability of already identified and promising molecular biomarkers, to promote individualisation of treatment for patients with endometrial cancer. Predominantly, but not exclusively, such biomarkers have shown to be interesting in retrospective analysis of our large prospectively collected MoMaTEC1 series.

Part 1: Performance of a phase 4 implementation trial for optimised stratification of surgical treatment, specifically the performance of (para-aortic and pelvic) lymphadenectomy guided by validated biomarkers.

Part 2: Performance of a phase 2b clinical biomarker study to evaluate the predictive potential of the biomarker stathmin for taxane treatment response in endometrial and ovarian cancer. In this study stathmin will be used as integrated biomarker.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haukeland University Hospital
• Treatments: Taxane

Criteria

Inclusion Criteria part 1:

All patients referred to a participating research centre with suspicion of or confirmed endometrial cancer.

Exclusion Criteria part 1:

1. Patients who do not have endometrial cancer

2. Patients who will or cannot give informed consent (including language barriers)

3. Patients <18 years of age

4. Patients who will not get surgical treatment for their endometrial cancer

Inclusion criteria part 2:

1. Patients with endometrial or epithelial ovarian cancer who following routine clinical guidelines are offered weekly taxane (paclitaxel) treatment. This will often be a third or fourth line treatment, i.e. patients with advanced disease.

2. Technical possibility to obtain a new tissue biopsy to determine stathmin level in the tumour recurrence.

Exclusion criteria part 2:

1. Patients not suffering from endometrial or epithelial ovarian cancer

2. Patients <18 years of age

3. Patients who do not agree to the proposed treatment or will receive (part of) the treatment in a non-participating centre

4. Patients who cannot or do not want to give informed consent (including language barriers)