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Taking people in NorwayPhase 4

Testing biomarker-guided surgery and taxane treatment in endometrial cancer

Tests biomarker-guided lymph node removal and taxane treatment in adults with endometrial cancer.

Plain-language title generated from the registry record
Registry title: Biomarker Guided Treatment in Gynaecological Cancer

Key facts

Where
Ålesund, Bergen, Førde, Kristiansand, Oslo, Stavanger, and Trondheim, NorwaySee the 7 sites
Phase
Phase 4

Could this be for you?

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 95 years old?

Source: NCT02543710, who can take part

Where in Norway

  • Ålesund HospitalÅlesund, NorwayTaking people
  • Women's hospital, Haukeland university hospitalBergen, NorwayTaking people
  • Førde Central HospitalFørde, NorwayTaking people
  • Sørlandet hospitalKristiansand, NorwayNot yet recruiting
  • Akershus University HospitalOslo, NorwayTaking people
  • Stavanger University HospitalStavanger, NorwayTaking people
  • St. Olav University HospitalTrondheim, NorwayTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
Print a page for my doctor

Trial details

Who runs it
Haukeland University Hospital
Trial code
NCT02543710
Record updated
28 March 2017
Original description
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.Read full original descriptionShow less

Biomarker Guided Treatment in Gynaecological Cancer

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.

Inclusion: 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.

Exclusion: 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; Patients <18 years of age; Patients <18 years of age; 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).

ClinicalTrials.gov NCT02543710