NCT06113094

Brief Summary

Desmoid tumors, also called aggressive fibromatosis, are rare, locally invasive tumors with no potential for metastasis. The incidence is approximately 2 to 4 per million per year in the general population. The "watch and wait" policy is the standard of care for newly diagnosed patients in Europe. Patients who progress have first-line medical treatment, surgery is no longer the treatment because there is a high rate of recurrence (\> 60%) and radiotherapy is not very suitable because the patients are often young and the tumors are large. Cryoablation seems to be an effective therapeutic option that should be evaluated.

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
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2020

Typical duration for all trials

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

July 7, 2020

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

November 14, 2022

Completed
12 months until next milestone

First Posted

Study publicly available on registry

November 2, 2023

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

November 2, 2023

Status Verified

November 1, 2022

Enrollment Period

3.4 years

First QC Date

November 14, 2022

Last Update Submit

October 30, 2023

Conditions

Desmoid Tumors

Keywords

Desmoid tumorsFibromatosisInvasive tumorsRadiotherapyCryoablation

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival assessed using RECIST(Response evaluation criteria in solid tumors) criteria

    at 6 months after cryoablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patient (≥18 years old) having undergone cryoablation for an advanced desmoid tumor refractory to medical treatment

You may qualify if:

  • Adult patient (≥18 years old)
  • Having undergone cryoablation for an advanced desmoid tumor refractory to medical treatment
  • Having not expressed their opposition, after being informed, to the reuse of their data for the purposes of this research.

You may not qualify if:

  • Subject who expressed their opposition to participating in the study
  • Patient already included in another ongoing study
  • Subject under guardianship or curatorship
  • Subject under safeguard of justice

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service d'Imagerie Interventionnelle - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Desmoid TumorsFibroma

Condition Hierarchy (Ancestors)

Neoplasms, Fibrous TissueNeoplasms, Connective TissueNeoplasms, Connective and Soft TissueNeoplasms by Histologic TypeNeoplasms

Central Study Contacts

Pierre AULOGE, MD

CONTACT

33 3 69 55 15 26pierre.auloge@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 14, 2022

First Posted

November 2, 2023

Study Start

July 7, 2020

Primary Completion

December 1, 2023

Study Completion

December 31, 2023

Last Updated

November 2, 2023

Record last verified: 2022-11

Locations

FR(1)