Immunological Phenotype of Desmoid-fibromatosis-affected Patients.

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07496242

Enrollment

200

Registered

2026-03-27

Start date

2025-05-27

Completion date

2026-12-01

Last updated

2026-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Desmoid-Type Fibromatosis

Brief 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Levels of circulating tumor DNA (ctDNA)	Baseline and every 3 months during the first year, then every 6 months up to 36 months.	Quantification of circulating tumor DNA levels in peripheral blood samples to evaluate their association with the clinical course of the disease (stable disease, spontaneous regression, or progression according to RECIST criteria).
Phenotypic profile of circulating immune cells	Baseline and every 3 months during the first year, then every 6 months up to 36 months.	Characterization of circulating immune cell subsets in peripheral blood samples using immunophenotyping assays.
Tumor immune microenvironment characteristics	Baseline.	Assessment of immune cell infiltration and inflammatory markers in available tumor biopsy samples to characterize the tumor immune microenvironment.
Clinical disease course	From baseline up to 36 months.	Clinical disease course assessed as stable disease, spontaneous regression, or progression according to RECIST criteria.

Countries

Italy, Netherlands

Contacts

CONTACTChiara Colombo, MD, Surgical Oncologist

chiara.colombo@istitutotumori.mi.it+390223902740

PRINCIPAL_INVESTIGATORChiara Colombo, MD, Surgical Oncologist

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano

Outcome results