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NCT Number: NCT07496242

Immunological Phenotype of Desmoid-fibromatosis-affected Patients.

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.

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Key information

Conditions

Desmoid-Type Fibromatosis Desmoid Tumors Fibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neoplasms, Fibrous Tissue

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

IRCCS Istituto di Candiolo Fondazione del Piemonte per l'Oncologia, Candiolo, Italy

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Levels of circulating tumor DNA (ctDNA)

    Time frame: 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).

  2. Phenotypic profile of circulating immune cells

    Time frame: 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.

  3. Tumor immune microenvironment characteristics

    Time frame: Baseline.

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

  4. Clinical disease course

    Time frame: From baseline up to 36 months.

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

Study contacts

Contact information is provided by the study sponsor or research team.

Chiara Colombo, MD, Surgical Oncologist

CONTACT

[email protected]

+390223902740

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Other

Collaborators

  • Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo
  • Azienda Ospedaliero-Universitaria Careggi
  • Azienda USL Toscana Centro
  • Campus Bio-Medico University
  • Candiolo Cancer Institute - IRCCS
  • Erasmus University Rotterdam
  • Istituto Oncologico Veneto IRCCS

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 27, 2026
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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