Peripheral Primitive Fibromatosis

NCT ID: NCT01801176

Last Updated: 2016-06-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2018-05-31

Brief Summary

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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

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Conditions

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Peripheral Primitive Fibromatosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Study Groups

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Initial monitoring group

Group Type EXPERIMENTAL

MRI

Intervention Type 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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institut Gustave Roussy

Villejuif, Val de Marne, France

Site Status RECRUITING

Countries

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France

Facility Contacts

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Sylvie BONVALOT, MD

Role: primary

0142114383 ext. +33

Thibaud MOTREFF

Role: backup

0142116643 ext. +33

Other Identifiers

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2011/1774

Identifier Type: OTHER

Identifier Source: secondary_id

2011-A01188-33

Identifier Type: -

Identifier Source: org_study_id

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