RecruitingNCT07496242

Immunological Phenotype of Desmoid-fibromatosis-affected Patients.

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


Sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Enrollment

200 participants

Start Date

May 27, 2025

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria2

  • 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.

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Locations(8)

IRCCS Istituto di Candiolo Fondazione del Piemonte per l'Oncologia

Candiolo, Italy

Azienda Ospedaliero Universitaria Careggi

Florence, Italy

Azienda Usl Toscana centro

Florence, Italy

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy

IRCCS Istituto Oncologico Veneto IOV

Padova, Italy

Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"

Palermo, Italy

Università Campus Bio-Medico

Rome, Italy

Erasmus University Medical Centre

Rotterdam, Netherlands

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NCT07496242