Peripheral Primitive Fibromatosis. Study Evaluating a Simple Initial Monitoring With Search of Scalability Predictive Factors and Registration of Treatments in Case of Progression
N/A
18 Years
N/A
18 Years
N/A
Open (Enrolling)
Both
Peripheral Primitive Fibromatosis
Both
Peripheral Primitive Fibromatosis
Trial Information
Peripheral Primitive Fibromatosis. Study Evaluating a Simple Initial Monitoring With Search of Scalability Predictive Factors and Registration of Treatments in Case of Progression
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
Type of Study:
Interventional
Study Design:
Intervention Model: Single Group Assignment, Masking: Open Label
Outcome Measure:
Progression Free Survival
Outcome Time Frame:
assessed up to 3 years
Safety Issue:
No
Authority:
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study ID:
2011-A01188-33
NCT ID:
NCT01801176
Start Date:
May 2012
Completion Date:
May 2018
Related Keywords:
- Peripheral Primitive Fibromatosis
- proved by biopsy
- Fibroma
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