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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| phase 4 implementation study | Experimental | The historical MoMaTEC1 outcome data, collected from 2001-2015 serve as control arm. These data have been rigorously collected and quality controlled with extensive clinical annotation and follow-up data, and reflect the outcome in (for a larger part) the same population as expected for MoMaTEC2 as there have not been major changes in surgical or medical treatment for endometrial cancer in this time period that could cause confounding. Internal validity, and to a degree also external validity, covering practice in multiple countries, should in this way be assured. |
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| phase 2b biomarker study | Experimental | For the current study, stathmin is used as an integrated marker and does not dictate treatment modality, therefore there is no requirement for a control arm. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biomarker (ER/PR) guided lymphadenectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| number of recurrences after primary treatment | The 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. | 5 year after diagnosis |
| stathmin levels | stathmin level will be measured in metastatic tissue and related to response to treatment using Response Evaluation Criteria In Solid Tumors (RECIST) criteria | duration of complete or partial treatment response in metastatic setting (expected duration less than one year) |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of life measurements | Quality of life will be measured through validated questionnaires (EORTC QLQ-C30 and EORTC QLQ-EN24). | 5 years post treatment |
| correlation of stathmin llevels in tumor, urine and blood |
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Inclusion Criteria part 1:
All patients referred to a participating research centre with suspicion of or confirmed endometrial cancer.
Exclusion Criteria part 1:
Inclusion criteria part 2:
Exclusion criteria part 2:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jone Trovik, MD PhD Prof | Contact | +4755974200 | jone.trovik@k2.uib.no | |
| Henrica MJ Werner, MD PhD MRCOG | Contact | +4755974200 | henrica.werner@k2.uib.no |
| Name | Affiliation | Role |
|---|---|---|
| Henrica MJ Werner, MD PhD MRCOG | Haukeland University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radboud university hospital | Not yet recruiting | Nijmegen | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34400137 | Derived | 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. |
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| ID | Term |
|---|---|
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D015415 | Biomarkers |
| ID | Term |
|---|---|
| D001685 | Biological Factors |
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| Biomarker guided weekly taxane treatment in endometrial/ ovarian cancer | Drug | 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. |
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stathmin tumor levels, urine levels and blood levels will be correlated.
| duration of complete or partial treatment response in metastatic setting (expected duration less than one year) |
| Women's hospital, Haukeland university hospital | Recruiting | Bergen | Hordaland | 5053 | Norway |
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| Ålesund hospital | Recruiting | Ålesund | 6017 | Norway |
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| Førde central hospital | Recruiting | Førde | 6812 | Norway |
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| Sørlandet hospital | Not yet recruiting | Kristiansand | 4604 | Norway |
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| Akershus University hospital | Recruiting | Oslo | Norway |
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| Stavanger university hospital | Recruiting | Stavanger | 4011 | Norway |
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| St Olav university hospital | Recruiting | Trondheim | 7006 | Norway |
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| Spsk No 1 | Recruiting | Lublin | 20-081 | Poland |
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| D009369 |
| Neoplasms |
| D014591 | Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |