Peripheral Primitive Fibromatosis
Not Applicable
- Conditions
- Peripheral Primitive Fibromatosis
- Interventions
- Other: MRI
- 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
- Arm && Interventions
Group Intervention Description Initial monitoring group MRI -
- 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
Trial Locations
- Locations (1)
Institut Gustave Roussy
🇫🇷Villejuif, Val de Marne, France