Actively Recruiting

Phase 4
Age: 18Years - 95Years
FEMALE
NCT02543710

Biomarker Guided Treatment in Gynaecological Cancer

Led by Haukeland University Hospital · Updated on 2017-03-28

1300

Participants Needed

9

Research Sites

948 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Biomarker Guided Treatment in Gynaecological Cancer

Who Can Participate

Age: 18Years - 95Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients referred to a participating research center with suspected or confirmed endometrial cancer
  • Patients with endometrial or epithelial ovarian cancer who are offered weekly taxane (paclitaxel) treatment following routine clinical guidelines
  • Ability to obtain a new tissue biopsy for stathmin level analysis in tumor recurrence
  • Female patients aged 18 to 95 years
Not Eligible

You will not qualify if you...

  • Patients without endometrial cancer (for part 1) or without endometrial or epithelial ovarian cancer (for part 2)
  • Patients under 18 years of age
  • Patients who cannot or do not give informed consent, including due to language barriers
  • Patients who will not undergo surgical treatment for their endometrial cancer
  • Patients who do not agree to the proposed treatment or will receive treatment in a non-participating center

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 9 locations

1

Radboud university hospital

Nijmegen, Netherlands

Not Yet Recruiting

2

Women's hospital, Haukeland university hospital

Bergen, Hordaland, Norway, 5053

Actively Recruiting

3

Ålesund hospital

Ålesund, Norway, 6017

Actively Recruiting

4

Førde central hospital

Førde, Norway, 6812

Actively Recruiting

5

Sørlandet hospital

Kristiansand, Norway, 4604

Not Yet Recruiting

6

Akershus University hospital

Oslo, Norway

Actively Recruiting

7

Stavanger university hospital

Stavanger, Norway, 4011

Actively Recruiting

8

St Olav university hospital

Trondheim, Norway, 7006

Actively Recruiting

9

Spsk No 1

Lublin, Poland, 20-081

Actively Recruiting

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Research Team

J

Jone Trovik, MD PhD Prof

CONTACT

H

Henrica MJ Werner, MD PhD MRCOG

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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