Fact CheckerSign in

NCT02543710RecruitingPhase 4

Biomarker Guided Treatment in Gynaecological Cancer

Source: ClinicalTrials.gov · Last updated 28 Mar 2017 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
1300 (estimated)
First submitted
7 Jul 2015
Start date
Oct 2015
Primary completion date
Dec 2020
Lead sponsor
Haukeland University Hospital
NCT number
NCT02543710

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 1300
  • From Oct 2015 to the primary completion date, Dec 2020
  • 9 sites in 3 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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

Age

  • Patients \<18 years of age
  • Patients \<18 years of age

Other

  • 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)

Who the study is looking for

  • 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.

Age in the registry: 18 years to 95 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Radboud university hospital
Coordinator of this site? Confirm its status
NijmegenNetherlandsNot yet recruiting
Ålesund Hospital
Coordinator of this site? Confirm its status
ÅlesundNorwayRecruiting
Women's hospital, Haukeland university hospital
Coordinator of this site? Confirm its status
BergenNorwayRecruiting
Førde Central Hospital
Coordinator of this site? Confirm its status
FørdeNorwayRecruiting
Sørlandet hospital
Coordinator of this site? Confirm its status
KristiansandNorwayNot yet recruiting
Akershus University Hospital
Coordinator of this site? Confirm its status
OsloNorwayRecruiting
Stavanger University Hospital
Coordinator of this site? Confirm its status
StavangerNorwayRecruiting
St. Olav University Hospital
Coordinator of this site? Confirm its status
TrondheimNorwayRecruiting
Spsk No 1
Coordinator of this site? Confirm its status
LublinPolandRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.