Biomarker Guided Treatment in Gynaecological Cancer

Who is this study for? Patients with Endometrial Cancer
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 4
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
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 95
Healthy Volunteers: f
View:

⁃ 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.

Locations
Other Locations
Netherlands
Radboud university hospital
NOT_YET_RECRUITING
Nijmegen
Norway
Ålesund hospital
RECRUITING
Ålesund
Women's hospital, Haukeland university hospital
RECRUITING
Bergen
Førde central hospital
RECRUITING
Førde
Sørlandet hospital
NOT_YET_RECRUITING
Kristiansand
Akershus University hospital
RECRUITING
Oslo
Stavanger university hospital
RECRUITING
Stavanger
St Olav university hospital
RECRUITING
Trondheim
Poland
Spsk No 1
RECRUITING
Lublin
Contact Information
Primary
Jone Trovik, MD PhD Prof
jone.trovik@k2.uib.no
+4755974200
Backup
Henrica MJ Werner, MD PhD MRCOG
henrica.werner@k2.uib.no
+4755974200
Time Frame
Start Date: 2015-10
Estimated Completion Date: 2033-12
Participants
Target number of participants: 1300
Treatments
Experimental: phase 4 implementation study
The historical MoMaTEC1 outcome data, collected from 2001-2015 serve as control arm. These data have been rigorously collected and quality controlled with extensive clinical annotation and follow-up data, and reflect the outcome in (for a larger part) the same population as expected for MoMaTEC2 as there have not been major changes in surgical or medical treatment for endometrial cancer in this time period that could cause confounding. Internal validity, and to a degree also external validity, covering practice in multiple countries, should in this way be assured.
Experimental: phase 2b biomarker study
For the current study, stathmin is used as an integrated marker and does not dictate treatment modality, therefore there is no requirement for a control arm.
Related Therapeutic Areas
Sponsors
Leads: Haukeland University Hospital

This content was sourced from clinicaltrials.gov