NCT01801176

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 28, 2013

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2018

Completed
Last Updated

June 9, 2016

Status Verified

June 1, 2016

Enrollment Period

6 years

First QC Date

February 25, 2013

Last Update Submit

June 8, 2016

Conditions

Peripheral Primitive Fibromatosis

Keywords

proved by biopsy

Outcome Measures

Primary Outcomes (1)

  • Progression Free Survival

    assessed up to 3 years

Secondary Outcomes (1)

  • Functional result

    1 year

Study Arms (1)

Initial monitoring group

EXPERIMENTAL
Other: MRI

Interventions

MRIOTHER

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Peripheral primitive fibromatosis
  • Adults patients
  • Peripheral primitive fibromatosis proved by biopsy
  • Peripheral primitive fibromatosis R2 resected for which monitoring is decided
  • Patient information and informed consent signed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut Gustave Roussy

Villejuif, Val de Marne, 94805, France

RECRUITING

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2013

First Posted

February 28, 2013

Study Start

May 1, 2012

Primary Completion

May 1, 2018

Study Completion

May 1, 2018

Last Updated

June 9, 2016

Record last verified: 2016-06

Locations

FR(1)