Clinical trial NCT02543710: Biomarker Guided Treatment in Gynaecological Cancer
Official title: Biomarker Guided Treatment in Gynaecological Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Endometrial Cancer
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2015-09-07
Enrollment: 1300
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 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)

Primary outcomes:
measure: number of recurrences after primary treatment
timeFrame: 5 year after diagnosis
measure: stathmin levels
timeFrame: duration of complete or partial treatment response in metastatic setting (expected duration less than one year)
Secondary outcomes:
measure: Quality of life measurements
timeFrame: 5 years post treatment
measure: correlation of stathmin llevels in tumor, urine and blood
timeFrame: duration of complete or partial treatment response in metastatic setting (expected duration less than one year)
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud university hospital
city: Bergen
country: Norway
facility: Women's hospital, Haukeland university hospital
state: Hordaland
city: Alesund
country: Norway
facility: Ålesund hospital
city: Førde
country: Norway
facility: Førde central hospital
city: Kristiansand
country: Norway
facility: Sørlandet hospital
city: Oslo
country: Norway
facility: Akershus University hospital
city: Stavanger
country: Norway
facility: Stavanger university hospital
city: Trondheim
country: Norway
facility: St Olav university hospital
city: Lublin
country: Poland
facility: Spsk No 1
Study officials:
affiliation: Haukeland University Hospital
name: Henrica MJ Werner, MD PhD MRCOG
role: PRINCIPAL_INVESTIGATOR
References:
citation: Forsse D, Barbero ML, Werner HMJ, Woie K, Nordskar N, Berge Nilsen E, Ellstrom Engh M, Vistad I, Rege A, Saevik-Lode M, Andreasen S, Haldorsen IS, Trovik J, Krakstad C. Longitudinal effects of adjuvant chemotherapy and lymph node staging on patient-reported outcomes in endometrial cancer survivors: a prospective cohort study. Am J Obstet Gynecol. 2022 Jan;226(1):90.e1-90.e20. doi: 10.1016/j.ajog.2021.08.011. Epub 2021 Aug 13.