Immune profile of people with desmoid-type fibromatosis
Official title: Immunological Profile of Patients With Desmoid-type Fibromatosis Under Active Surveillance.
Run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · NCT07496242 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Locations | 8 sites (Candiolo and 7 other locations) |
| Status | Recruiting |
| Started | May 27, 2025 |
| Main results expected | August 31, 2026 |
| Study ends | December 2026 |
| Registry record updated | March 27, 2026 |
| Trial ID | NCT07496242 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: 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.
Who can join: the full rules
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 it's running
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Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy Recruiting -
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 -
IRCCS Istituto Oncologico Veneto IOV
Padova, Italy Not yet recruiting -
Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
Palermo, Italy Not yet recruiting
Show 2 more locations
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.