Biomarker Guided Treatment in Gynaecological Cancer

Last updated: March 24, 2017
Sponsor: Haukeland University Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Vaginal Cancer

Endometrial Cancer

Endometriosis

Treatment

N/A

Clinical Study ID

NCT02543710
2015/548
  • Ages 18-95
  • Female

Study 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

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)

Study Design

Total Participants: 1300
Study Start date:
October 01, 2015
Estimated Completion Date:
December 31, 2033

Connect with a study center

  • Radboud university hospital

    Nijmegen,
    Netherlands

    Site Not Available

  • Women's hospital, Haukeland university hospital

    Bergen, Hordaland 5053
    Norway

    Active - Recruiting

  • Ålesund hospital

    Alesund, 6017
    Norway

    Active - Recruiting

  • Førde central hospital

    Førde, 6812
    Norway

    Active - Recruiting

  • Sørlandet hospital

    Kristiansand, 4604
    Norway

    Site Not Available

  • Akershus University hospital

    Oslo,
    Norway

    Active - Recruiting

  • Stavanger university hospital

    Stavanger, 4011
    Norway

    Active - Recruiting

  • St Olav university hospital

    Trondheim, 7006
    Norway

    Active - Recruiting

  • Spsk No 1

    Lublin, 20-081
    Poland

    Active - Recruiting

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