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Immunological Profile of Patients With Desmoid-type Fibromatosis Under Active Surveillance.

Status: Recruiting
Location: See all (8) locations...
Study Type: Observational
SUMMARY

This observational study aims to characterize the molecular, phenotypic, and functional inflammatory and immunological profile of patients with sporadic desmoid-type fibromatosis undergoing either active surveillance or systemic therapy. The study includes analysis of the tumor immune microenvironment (TIME), circulating immune and inflammatory molecules, immune cell subsets, and circulating tumor DNA (ctDNA). The goal is to identify biomarkers associated with spontaneous or treatment-induced tumor regression and to evaluate potential correlations with specific ß-catenin mutations.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
IRCCS Istituto di Candiolo Fondazione del Piemonte per l'Oncologia
NOT_YET_RECRUITING
Candiolo
Azienda Ospedaliero Universitaria Careggi
NOT_YET_RECRUITING
Florence
Azienda Usl Toscana centro
NOT_YET_RECRUITING
Florence
Fondazione IRCCS Istituto Nazionale dei Tumori
RECRUITING
Milan
IRCCS Istituto Oncologico Veneto IOV
NOT_YET_RECRUITING
Padova
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
NOT_YET_RECRUITING
Palermo
Università Campus Bio-Medico
NOT_YET_RECRUITING
Rome
Netherlands
Erasmus University Medical Centre
NOT_YET_RECRUITING
Rotterdam
Contact Information
Primary
Chiara Colombo, MD, Surgical Oncologist
chiara.colombo@istitutotumori.mi.it
+390223902740
Time Frame
Start Date: 2025-05-27
Estimated Completion Date: 2026-12
Participants
Target number of participants: 200
Treatments
Patients under active surveillance
Patients with primary sporadic desmoid-type fibromatosis with measurable disease
Patients receiving systemic treatment
Patients with primary sporadic desmoid-type fibromatosis with measurable disease.
Related Therapeutic Areas
Sponsors
Collaborators: Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo, Azienda Ospedaliero-Universitaria Careggi, Erasmus University Rotterdam, Istituto Oncologico Veneto IRCCS, Campus Biomedico - Roma, Candiolo Cancer Institute - IRCCS, Azienda USL Toscana Centro
Leads: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

This content was sourced from clinicaltrials.gov

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