Cryoablation for Advanced and Refractory Desmoid Tumors

Desmoid Tumors Clinical Trial

— CARDT  

Official title:

Cryoablation for Advanced and Refractory Desmoid Tumors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06113094
• Other study ID #: 7884
• Status: Recruiting
• Start date: July 7, 2020
• Est. completion date: December 31, 2023

Study information

• Verified date: November 2022
• Source: University Hospital, Strasbourg, France
• Contact: Pierre AULOGE, MD
• Phone: 33 3 69 55 15 26
• Email: pierre.auloge[@]chru-strasbourg.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2023
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

• 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.

Exclusion criteria:

• 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

Related Conditions & MeSH terms

• Desmoid Tumors

Locations

Country	Name	City	State
France	Service d'Imagerie Interventionnelle - CHU de Strasbourg - France	Strasbourg

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival assessed using RECIST(Response evaluation criteria in solid tumors) criteria		at 6 months after cryoablation