NCT02543710 Biomarker Guided Treatment in Gynaecological Cancer
| NCT ID | NCT02543710 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Haukeland University Hospital |
| Condition | Endometrial Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,300 participants |
| Start Date | 2015-10 |
| Primary Completion | 2020-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 1,300 participants in total. It began in 2015-10 with a primary completion date of 2020-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility 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)
Contact & Investigator
Henrica MJ Werner, MD PhD MRCOG
PRINCIPAL INVESTIGATOR
Haukeland University Hospital
Frequently Asked Questions
Who can join the NCT02543710 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 95 Years, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT02543710 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT02543710 currently recruiting?
Yes, NCT02543710 is actively recruiting participants. Contact the research team at jone.trovik@k2.uib.no for enrollment information.
Where is the NCT02543710 trial being conducted?
This trial is being conducted at Nijmegen, Netherlands, Bergen, Norway, Ålesund, Norway, Førde, Norway and 5 additional locations.
Who is sponsoring the NCT02543710 clinical trial?
NCT02543710 is sponsored by Haukeland University Hospital. The principal investigator is Henrica MJ Werner, MD PhD MRCOG at Haukeland University Hospital. The trial plans to enroll 1,300 participants.
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