Peripheral Primitive Fibromatosis
Conditions
Keywords
proved by biopsy
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.
Interventions
OTHERMRI
MRI every 3 months during the first year and then every 6 months during the second year and then one MRI up to 36 months
Sponsors
Gustave Roussy, Cancer Campus, Grand Paris
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival | assessed up to 3 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional result | 1 year | Assessed with criteria for Adverse Effects-V4 scale once per year during the consultation |
Countries
France
Outcome results
None listed