Peripheral Primitive Fibromatosis
Not Applicable
- Conditions
- Peripheral Primitive Fibromatosis
- Registration Number
- NCT01801176
- Lead Sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Brief Summary
It's a monitoring study. The aim is to assess the progression free survival up to 3 years. Patients are not treated until progression. Search for scalability predictive factors and registration of treatments if progression.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Peripheral primitive fibromatosis
- Adults patients
- Peripheral primitive fibromatosis proved by biopsy
- Peripheral primitive fibromatosis R2 resected for which monitoring is decided
- MRI realized before inclusion
- Patient information and informed consent signed
Exclusion Criteria
- Local recur
- Head and neck topography
- Primitive fibromatosis R0 or R1 resected
- Specific medical treatment of fibromatosis
- Patient already included in an other clinical trial with an experimental molecule
- Persons deprived of liberty
- Impossibility to submit to the trial's medical follow-up for psychological, geographical or socials reasons
- Previous history of cancer
- Counter indication to the realization of an MRI
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Progression Free Survival assessed up to 3 years
- Secondary Outcome Measures
Name Time Method Functional result 1 year Assessed with criteria for Adverse Effects-V4 scale once per year during the consultation
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular pathways drive progression in peripheral primitive fibromatosis as studied in NCT01801176?
How does MRI-based monitoring compare to standard imaging protocols in managing peripheral primitive fibromatosis progression?
Which biomarkers correlate with disease stability in peripheral primitive fibromatosis during MRI surveillance?
What adverse events are associated with treatment regimens for progressive peripheral primitive fibromatosis post-MRI monitoring?
What drug classes are used for progressive peripheral primitive fibromatosis after initial MRI monitoring in NCT01801176?
Trial Locations
- Locations (1)
Institut Gustave Roussy
🇫🇷Villejuif, Val de Marne, France
Institut Gustave Roussy🇫🇷Villejuif, Val de Marne, France