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Biomarker Guided Treatment in Gynaecological Cancer

Biomarker Guided Treatment in Gynaecological Cancer

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02543710
Acronym
Momatec2
Enrollment
1300
Registered
2015-09-07
Start date
2015-10-31
Completion date
2033-12-31
Last updated
2017-03-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Endometrial Cancer

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.

Interventions

PROCEDUREBiomarker (ER/PR) guided lymphadenectomy

Lymphadenectomy in the pelvis and para-aortic, will, for patients who are considered otherwise low risk (endometrioid tumours grade 1 or 2, or grade 3 with \<50% myometrial infiltration (MI), with no sign of extrauterine disease), be dependent on the preoperative hormone receptor status (ER and PR). Patients will be defined low risk when endometrioid, grade 1 or 2, or grade 3 with \<50% MI, AND positive hormone receptor status for both ER AND PR. These patients will not undergo lymphadenectomy. Patients with endometrioid tumours grade 1 or 2, or grade 3 \<50% MI,, with either negative ER or PR status, are defined high risk and will undergo pelvic and para-aortic lymphadenectomy as part of their surgical procedure. Patients will receive routine clinical follow-up for 5 years. Follow-up data will be collected for the study, focusing on survival and recurrence of disease. All patients will, as part of the study fill out validated quality of life questionnaires (QoL) at follow-up.

DRUGBiomarker guided weekly taxane treatment in endometrial/ ovarian cancer

A 5mm tissue biopsy will be analysed for stathmin level in the recurrence as well as urine and a second 5mm biopsy on termination of study participation. The second biopsy could help explain why patients have stopped responding to the treatment. Determination of stathmin level both from the tissue and the urine will take place at the pathology department. Stathmin serves as an integrated biomarker, which enables a central biomarker analysis at Haukeland university hospital. Stathmin level is defined as high with an immunohistochemical score 9 (max score). All other scores are considered low. Pre-treatment all patients undergo CT or MRI, maximum 1 month prior to treatment start. During treatment, urine and bloods will be collected every treatment cycle (weekly basis). Imaging will take place every 8 treatment cycles. Treatment will continue until disease progression.

Sponsors

Haukeland University Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 95 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
number of recurrences after primary treatment5 year after diagnosisThe percentage of lymphadenectomy can be reduced safely and significantly, from 70% (MoMaTEC1 study results) to 30% in the MoMaTEC2 study through a better risk stratification of patients, especially better identification of low risk patients. Additionally The percentage of patients who need to be subjected to adjuvant (chemo) therapy can be reduced similarly from 20 to 10%, based on the same, optimised risk stratification and better identification of low risk patients. Patients will be rigorously followed during 5 years to detect any unexpected increase in the percentage of patients suffering a recurrence compared to the historical MoMaTEC1 cohort.
stathmin levelsduration of complete or partial treatment response in metastatic setting (expected duration less than one year)stathmin level will be measured in metastatic tissue and related to response to treatment using Response Evaluation Criteria In Solid Tumors (RECIST) criteria

Secondary

MeasureTime frameDescription
Quality of life measurements5 years post treatmentQuality of life will be measured through validated questionnaires (EORTC QLQ-C30 and EORTC QLQ-EN24).
correlation of stathmin llevels in tumor, urine and bloodduration of complete or partial treatment response in metastatic setting (expected duration less than one year)stathmin tumor levels, urine levels and blood levels will be correlated.

Countries

Netherlands, Norway, Poland

Contacts

Primary ContactJone Trovik, MD PhD Prof
jone.trovik@k2.uib.no+4755974200
Backup ContactHenrica MJ Werner, MD PhD MRCOG
henrica.werner@k2.uib.no+4755974200

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026