An observational study in Desmoid-Type Fibromatosis, sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. Recruiting at 8 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-27.
Sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Observational
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.
71 studies on the registry are indexed under Desmoid Tumors; 21 are open to participants now.
This study's planned enrollment of 200 is above the median of 100 across 19 observational studies indexed under Desmoid Tumors.
Browse Desmoid Tumors studies →Fondazione IRCCS Istituto Nazionale dei Tumori, Milano is the lead sponsor of 172 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Measurable disease
The amount of disease can be tracked with a defined measurement, so the study can see whether it shrinks or grows. It might be a tumour measured on a scan or, in some blood cancers such as myeloma, a marker measured in blood or urine.
The criteria or the study team say which measurement counts — having no tumour visible on a scan does not by itself rule you out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with primary sporadic desmoid-type fibromatosis with measurable disease
Patients with primary sporadic desmoid-type fibromatosis with measurable disease.
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.
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.
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.
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.
Plan to share: Yes — Aggregated clinical and molecular data generated from the study will be shared in scientific publications and presentations. These aggregated data will be made available after the publication of the main study results. Aggregated data will become available after publication of the primary results after the end of the study. Aggregated data will be available to researchers and clinicians through scientific publications and conference communications for scientific, educational, and research purposes, including further understanding of desmoid-type fibromatosis biology and clinical behavior. Data will be shared through peer-reviewed publications, conference presentations, and other scientific dissemination channels.
No publications or documents are linked to this record.
Started May 2025 (actual). Primary completion is estimated for Aug 2026, 15 months after the start.
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