- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Condiciones
Tipo de estudio
Inscripción (Anticipado)
Fase
- Fase 4
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Jone Trovik, MD PhD Prof
- Número de teléfono: +4755974200
- Correo electrónico: jone.trovik@k2.uib.no
Copia de seguridad de contactos de estudio
- Nombre: Henrica MJ Werner, MD PhD MRCOG
- Número de teléfono: +4755974200
- Correo electrónico: henrica.werner@k2.uib.no
Ubicaciones de estudio
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Alesund, Noruega, 6017
- Reclutamiento
- Ålesund Hospital
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Contacto:
- Margaret S Lode, MD
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Førde, Noruega, 6812
- Reclutamiento
- Førde Central Hospital
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Contacto:
- Jostein Tjugum, MD
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Contacto:
- marthe LT Larsson, MD
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Kristiansand, Noruega, 4604
- Aún no reclutando
- Sørlandet Hospital
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Contacto:
- Ane C Munk, MD, PhD
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Contacto:
- ingvild Vistad, MD, PhD
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Oslo, Noruega
- Reclutamiento
- Akershus University Hospital
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Contacto:
- marie E Engh, MD
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Stavanger, Noruega, 4011
- Reclutamiento
- Stavanger University Hospital
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Contacto:
- Elisabeth B Nilsen, MD
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Trondheim, Noruega, 7006
- Reclutamiento
- St Olav University Hospital
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Contacto:
- Nina Nordskar, MD
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Contacto:
- Solveig Tingulstad, MD
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Hordaland
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Bergen, Hordaland, Noruega, 5053
- Reclutamiento
- Women's hospital, Haukeland university hospital
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Contacto:
- Henrica MJ Werner, MD, PhD
- Número de teléfono: +4755974200
- Correo electrónico: heaw@helse-bergen.no
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Contacto:
- Jone Trovik, prof MD PhD
- Número de teléfono: +4755974200
- Correo electrónico: jone.trovik@uib.no
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Nijmegen, Países Bajos
- Aún no reclutando
- Radboud University Hospital
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Contacto:
- Hanny MA Pijnenborg, MD, PhD
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Contacto:
- Casper Reijne, MD
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Lublin, Polonia, 20-081
- Reclutamiento
- Spsk No 1
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Contacto:
- Bartolomiej Barczynski, MD, PhD
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: 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. |
Experimental: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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number of recurrences after primary treatment
Periodo de tiempo: 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
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Quality of life measurements
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Henrica MJ Werner, MD PhD MRCOG, Haukeland University Hospital
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Anticipado)
Finalización del estudio (Anticipado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2015/548
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
Ensayos clínicos sobre Cáncer endometrial
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University of Southern CaliforniaNational Cancer Institute (NCI)RetiradoHiperplasia endometrial atípica | Carcinoma endometrial recidivante | Adenocarcinoma endometrial | Carcinoma endometrial en estadio IA | Carcinoma endometrial en estadio IB | Carcinoma endometrial en estadio II | Carcinoma endometrial en estadio IIIA | Carcinoma endometrial en estadio IIIB | Carcinoma... y otras condiciones
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University Magna GraeciaDesconocidoTrastorno endometrial | Endometrio delgado | Espesor endometrial que no crece bajo estimulación con estrógenosItalia
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IVI MadridIgenomixTerminado
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IVI BilbaoTerminado
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Reproductive Medicine Associates of New JerseyTerminadoDisfunción EndometrialEstados Unidos
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Sohag UniversityAún no reclutandoCáncer endometrial e hiperplasia endometrialEgipto
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Fundación IVIInstituto Valenciano de Infertilidad, IVI VALENCIAReclutamiento
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IgenomixTerminadoReceptividad EndometrialEspaña, Bélgica, Brasil, Bulgaria, Japón, Panamá, Pavo
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Case Comprehensive Cancer CenterTerminadoCarcinoma endometrial en estadio IV | Carcinoma endometrial en estadio III | Carcinoma endometrial en estadio II | Carcinoma endometrial en estadio IEstados Unidos
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Odense University HospitalActivo, no reclutandoReceptividad EndometrialDinamarca
Ensayos clínicos sobre Biomarker (ER/PR) guided lymphadenectomy
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BiogenTerminadoEsclerosis múltipleSuecia, Reino Unido, Países Bajos, Bélgica, Canadá, Italia
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BiogenAcorda TherapeuticsTerminado
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Thomas Jefferson UniversityContext Therapeutics Inc.Activo, no reclutandoCarcinoma endometrial refractario | Adenocarcinoma Endometrioide Endometrial Refractario | Adenocarcinoma endometrial refractario | Adenocarcinoma de células claras endometriales refractario | Adenocarcinoma de células mixtas de endometrio refractario | Adenocarcinoma seroso endometrial refractario y otras condicionesEstados Unidos