Peripheral Primitive Fibromatosis | NCT01801176

Studies
Peripheral Primitive Fibromatosis

NCT01801176

Sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Status

Completed

Last Update Posted

Apr 6, 2026Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Peripheral Primitive Fibromatosis

Interventions

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2011/1774	Other Identifier	CSET number

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 11, 2012Actual

Primary Completion Date

May 25, 2020Actual

Completion Date

Dec 2, 2020Actual

First Submitted Date

Feb 25, 2013

First Submission Date that Met QC Criteria

Feb 27, 2013

First Posted Date

Feb 28, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 31, 2026

Last Update Posted Date

Apr 6, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Initial monitoring group	Experimental		Other: MRI

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Other	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	Initial monitoring group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Progression Free Survival		assessed up to 3 years

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institut Gustave Roussy		Villejuif	Val de Marne	94805	France