Peripheral Primitive Fibromatosis (WS-RT Fibro)

June 8, 2016 updated by: Gustave Roussy, Cancer Campus, Grand Paris

Peripheral Primitive Fibromatosis. Study Evaluating a Simple Initial Monitoring With Search of Scalability Predictive Factors and Registration of Treatments in Case of Progression

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Val de Marne
      • Villejuif, Val de Marne, France, 94805
        • Recruiting
        • Institut Gustave Roussy
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sylvie BONVALOT, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Initial monitoring group
Other: MRI
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Progression Free Survival
Time Frame: assessed up to 3 years
assessed up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functional result
Time Frame: 1 year
Assessed with criteria for Adverse Effects-V4 scale once per year during the consultation
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

February 25, 2013

First Submitted That Met QC Criteria

February 27, 2013

First Posted (Estimate)

February 28, 2013

Study Record Updates

Last Update Posted (Estimate)

June 9, 2016

Last Update Submitted That Met QC Criteria

June 8, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011-A01188-33
  • 2011/1774 (Other Identifier: CSET number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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