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- Klinische proef NCT02543710
Biomarker Guided Treatment in Gynaecological Cancer (Momatec2)
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.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Verwacht)
Fase
- Fase 4
Contacten en locaties
Studiecontact
- Naam: Jone Trovik, MD PhD Prof
- Telefoonnummer: +4755974200
- E-mail: jone.trovik@k2.uib.no
Studie Contact Back-up
- Naam: Henrica MJ Werner, MD PhD MRCOG
- Telefoonnummer: +4755974200
- E-mail: henrica.werner@k2.uib.no
Studie Locaties
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Nijmegen, Nederland
- Nog niet aan het werven
- Radboud University Hospital
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Contact:
- Hanny MA Pijnenborg, MD, PhD
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Contact:
- Casper Reijne, MD
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Alesund, Noorwegen, 6017
- Werving
- Alesund Hospital
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Contact:
- Margaret S Lode, MD
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Førde, Noorwegen, 6812
- Werving
- Førde Central Hospital
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Contact:
- Jostein Tjugum, MD
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Contact:
- marthe LT Larsson, MD
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Kristiansand, Noorwegen, 4604
- Nog niet aan het werven
- Sørlandet Hospital
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Contact:
- Ane C Munk, MD, PhD
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Contact:
- ingvild Vistad, MD, PhD
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Oslo, Noorwegen
- Werving
- Akershus University Hospital
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Contact:
- marie E Engh, MD
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Stavanger, Noorwegen, 4011
- Werving
- Stavanger University Hospital
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Contact:
- Elisabeth B Nilsen, MD
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Trondheim, Noorwegen, 7006
- Werving
- St Olav University Hospital
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Contact:
- Nina Nordskar, MD
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Contact:
- Solveig Tingulstad, MD
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Hordaland
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Bergen, Hordaland, Noorwegen, 5053
- Werving
- Women's hospital, Haukeland university hospital
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Contact:
- Henrica MJ Werner, MD, PhD
- Telefoonnummer: +4755974200
- E-mail: heaw@helse-bergen.no
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Contact:
- Jone Trovik, prof MD PhD
- Telefoonnummer: +4755974200
- E-mail: jone.trovik@uib.no
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Lublin, Polen, 20-081
- Werving
- Spsk No 1
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Contact:
- Bartolomiej Barczynski, MD, PhD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria part 1:
All patients referred to a participating research centre with suspicion of or confirmed endometrial cancer.
Exclusion Criteria part 1:
- Patients who do not have endometrial cancer
- Patients who will or cannot give informed consent (including language barriers)
- Patients <18 years of age
- Patients who will not get surgical treatment for their endometrial cancer
Inclusion criteria part 2:
- 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.
Exclusion criteria part 2:
- Patients not suffering from endometrial or epithelial ovarian cancer
- Patients <18 years of age
- 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)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Niet-gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: phase 4 implementation study
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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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. |
Experimenteel: phase 2b biomarker study
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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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. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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number of recurrences after primary treatment
Tijdsspanne: 5 year after diagnosis
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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.
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5 year after diagnosis
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stathmin levels
Tijdsspanne: duration of complete or partial treatment response in metastatic setting (expected duration less than one year)
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stathmin level will be measured in metastatic tissue and related to response to treatment using Response Evaluation Criteria In Solid Tumors (RECIST) criteria
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duration of complete or partial treatment response in metastatic setting (expected duration less than one year)
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Quality of life measurements
Tijdsspanne: 5 years post treatment
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Quality of life will be measured through validated questionnaires (EORTC QLQ-C30 and EORTC QLQ-EN24).
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5 years post treatment
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correlation of stathmin llevels in tumor, urine and blood
Tijdsspanne: duration of complete or partial treatment response in metastatic setting (expected duration less than one year)
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stathmin tumor levels, urine levels and blood levels will be correlated.
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duration of complete or partial treatment response in metastatic setting (expected duration less than one year)
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Henrica MJ Werner, MD PhD MRCOG, Haukeland University Hospital
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 2015/548
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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University of UtahNational Cancer Institute (NCI)WervingVermoeidheid | Sedentaire levensstijl | Gemetastaseerd prostaatcarcinoom | Stadium IV prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVA prostaatkanker AJCC (American Joint Committee on Cancer) v8 | Stadium IVB prostaatkanker AJCC (American Joint Committee on Cancer) v8Verenigde Staten
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Georgetown UniversityNational Cancer Institute (NCI); American Cancer Society, Inc.; Susan G. Komen...VoltooidBestudeer Chinese vrouwen die zich niet hebben gehouden aan de richtlijnen voor screening op mammografie van de American Cancer SocietyVerenigde Staten
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BioNTech SESeventh Framework ProgrammeVoltooidBorstkanker (Triple Negative Breast Cancer (TNBC))Zweden, Duitsland
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Novartis PharmaceuticalsVoltooidGeavanceerde Triple Negative Breast Cancer (TNBC) met hoge TAM'sFrankrijk, Italië, Oostenrijk, Taiwan, Verenigde Staten, Spanje, Australië, Korea, republiek van, België, Duitsland, Hongkong, Kalkoen
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Rashmi Verma, MDNational Cancer Institute (NCI)WervingCastratieresistent prostaatcarcinoom | Gemetastaseerd prostaatadenocarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
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Jonsson Comprehensive Cancer CenterNog niet aan het wervenProstaatcarcinoom | Stadium IVB Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
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Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI); National Institutes of Health (NIH)Nog niet aan het wervenAnatomische fase II borstkanker AJCC v8 | Anatomische fase III borstkanker AJCC v8 | Borstcarcinoom in een vroeg stadium | Anatomische fase I Borstkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
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Jonsson Comprehensive Cancer CenterIngetrokkenProstaat Adenocarcinoom | Prostaatkanker stadium II AJCC v8 | Stadium IIC prostaatkanker AJCC v8 | Stadium IIA prostaatkanker AJCC v8 | Stadium IIB prostaatkanker AJCC v8 | Fase I Prostaatkanker American Joint Committee on Cancer (AJCC) v8Verenigde Staten
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University of Southern CaliforniaNational Cancer Institute (NCI)WervingLokaal gevorderd pancreasadenocarcinoom | Inoperabel pancreasadenocarcinoom | Fase III Pancreaskanker American Joint Committee on Cancer v8Verenigde Staten
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Mayo ClinicNational Cancer Institute (NCI)VoltooidRefractair plasmacelmyeloom | DS stadium I plasmacelmyeloom | DS stadium II plasmacelmyeloom | DS stadium III plasmacelmyeloomVerenigde Staten
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ECOG-ACRIN Cancer Research GroupNational Cancer Institute (NCI)Actief, niet wervendPlasmacelmyeloomVerenigde Staten, Puerto Rico