Immune profile of people with desmoid-type fibromatosis
Immunological Profile of Patients With Desmoid-type Fibromatosis Under Active Surveillance.
This project will test whether immune and inflammatory signals in tumors and blood can explain why some people with sporadic desmoid-type fibromatosis get better on their own or after systemic treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Locations | 8 sites (Candiolo and 7 other locations) |
| Trial ID | NCT07496242 on ClinicalTrials.gov |
What this trial studies
This observational multicenter project collects tumor samples and blood from patients with primary sporadic desmoid-type fibromatosis who are either under active surveillance or receiving systemic therapy. Investigators will analyze the tumor immune microenvironment, circulating immune and inflammatory molecules, immune cell subsets, and circulating tumor DNA (ctDNA). Results will be correlated with specific ß-catenin mutations to look for biomarkers linked to spontaneous or treatment-induced tumor regression. The aim is to define immune and molecular signatures that differentiate regressing from stable or progressing disease.
Who should consider this trial
Good fit: Adults with primary sporadic desmoid-type fibromatosis who have measurable disease and are either being actively monitored without immediate treatment or are receiving systemic therapy are the intended participants.
Not a fit: Patients without measurable disease, those with hereditary (FAP-associated) desmoids, or individuals unwilling/unable to provide tumor or blood samples are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, the findings could help doctors predict which patients are likely to regress or respond to therapy and guide more personalized monitoring and treatment decisions.
How similar studies have performed: Small prior studies have described immune involvement and links to ß-catenin in desmoid tumors, but combining detailed tumor immune microenvironment profiling with circulating markers and ctDNA is relatively novel and not yet proven to guide care.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with primary sporadic desmoid-type fibromatosis with measurable disease under active surveillance * Patients with primary sporadic desmoid-type fibromatosis with measurable disease receiving systemic treatment.
Where this trial is running
Candiolo and 7 other locations
- IRCCS Istituto di Candiolo Fondazione del Piemonte per l'Oncologia — Candiolo, Italy (Not_yet_recruiting)
- Azienda Ospedaliero Universitaria Careggi — Florence, Italy (Not_yet_recruiting)
- Azienda Usl Toscana centro — Florence, Italy (Not_yet_recruiting)
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy (Recruiting)
- IRCCS Istituto Oncologico Veneto IOV — Padova, Italy (Not_yet_recruiting)
- Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" — Palermo, Italy (Not_yet_recruiting)
- Università Campus Bio-Medico — Rome, Italy (Not_yet_recruiting)
- Erasmus University Medical Centre — Rotterdam, Netherlands (Not_yet_recruiting)
Study contacts
- Principal investigator: Chiara Colombo, MD, Surgical Oncologist — Fondazione IRCCS Istituto Nazionale dei Tumori di Milano
- Study coordinator: Chiara Colombo, MD, Surgical Oncologist
- Email: chiara.colombo@istitutotumori.mi.it
- Phone: +390223902740
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.