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Immunological Phenotype of Desmoid-fibromatosis-affected Patients.

ConditionDesmoid-Type Fibromatosis
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

None

Trial population

* 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants
are grouped into 2 trial groups
Group A: Patients under active surveillance
Group B: Patients receiving systemic treatment

Trial outcomes

Primary outcomes

1

Levels of circulating tumor DNA (ctDNA)

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).

Time frame
Baseline and every 3 months during the first year, then every 6 months up to 36 months.
2

Phenotypic profile of circulating immune cells

Characterization of circulating immune cell subsets in peripheral blood samples using immunophenotyping assays.

Time frame
Baseline and every 3 months during the first year, then every 6 months up to 36 months.
3

Tumor immune microenvironment characteristics

Assessment of immune cell infiltration and inflammatory markers in available tumor biopsy samples to characterize the tumor immune microenvironment.

Time frame
Baseline.
4

Clinical disease course

Clinical disease course assessed as stable disease, spontaneous regression, or progression according to RECIST criteria.

Time frame
From baseline up to 36 months.

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Lead sponsor

Campus Biomedico - Roma

Collaborator

Candiolo Cancer Institute - IRCCS

Collaborator

Azienda Ospedaliero-Universitaria Careggi

Collaborator

Azienda USL Toscana Centro

Collaborator

Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo

Collaborator

Erasmus University Rotterdam

Collaborator

Istituto Oncologico Veneto IRCCS

Collaborator

Source ClinicalTrials.gov
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