NCT02543710RecruitingPhase 4
Biomarker Guided Treatment in Gynaecological Cancer
Source: ClinicalTrials.gov · Last updated 28 Mar 2017 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 1300 (estimated)
- First submitted
- 7 Jul 2015
- Start date
- Oct 2015
- Primary completion date
- Dec 2020
- Lead sponsor
- Haukeland University Hospital
- Diseases
- Endometrial cancer
- NCT number
- NCT02543710
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 1300
- From Oct 2015 to the primary completion date, Dec 2020
- 9 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients who do not have endometrial cancer
- Patients who will not get surgical treatment for their endometrial cancer
- Patients not suffering from endometrial or epithelial ovarian cancer
Age
- Patients \<18 years of age
- Patients \<18 years of age
Other
- Patients who will or cannot give informed consent (including language barriers)
- Patients who do not agree to the proposed treatment or will receive (part of) the treatment in a non-participating centre
- Patients who cannot or do not want to give informed consent (including language barriers)
Who the study is looking for
- All patients referred to a participating research centre with suspicion of or confirmed endometrial cancer.
- 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.
- Technical possibility to obtain a new tissue biopsy to determine stathmin level in the tumour recurrence.
Age in the registry: 18 years to 95 years · Sex: Female · Does not accept healthy volunteers
Sites (9)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Radboud university hospital Coordinator of this site? Confirm its status | Nijmegen | Netherlands | Not yet recruiting |
| Ålesund Hospital Coordinator of this site? Confirm its status | Ålesund | Norway | Recruiting |
| Women's hospital, Haukeland university hospital Coordinator of this site? Confirm its status | Bergen | Norway | Recruiting |
| Førde Central Hospital Coordinator of this site? Confirm its status | Førde | Norway | Recruiting |
| Sørlandet hospital Coordinator of this site? Confirm its status | Kristiansand | Norway | Not yet recruiting |
| Akershus University Hospital Coordinator of this site? Confirm its status | Oslo | Norway | Recruiting |
| Stavanger University Hospital Coordinator of this site? Confirm its status | Stavanger | Norway | Recruiting |
| St. Olav University Hospital Coordinator of this site? Confirm its status | Trondheim | Norway | Recruiting |
| Spsk No 1 Coordinator of this site? Confirm its status | Lublin | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.