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| Name | Class |
|---|---|
| Campus Biomedico - Roma | UNKNOWN |
| Candiolo Cancer Institute - IRCCS | OTHER |
| Azienda Ospedaliero-Universitaria Careggi | OTHER |
| Azienda USL Toscana Centro |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients under active surveillance | Patients with primary sporadic desmoid-type fibromatosis with measurable disease | ||
| Patients receiving systemic treatment | Patients with primary sporadic desmoid-type fibromatosis with measurable disease. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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. | 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. | Baseline. |
| Clinical disease course | Clinical disease course assessed as stable disease, spontaneous regression, or progression according to RECIST criteria. | From baseline up to 36 months. |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chiara Colombo, MD, Surgical Oncologist | Contact | +390223902740 | chiara.colombo@istitutotumori.mi.it |
| Name | Affiliation | Role |
|---|---|---|
| Chiara Colombo, MD, Surgical Oncologist | Fondazione IRCCS Istituto Nazionale dei Tumori di Milano | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Istituto di Candiolo Fondazione del Piemonte per l'Oncologia | Not yet recruiting | Candiolo | Italy |
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.
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| ID | Term |
|---|---|
| D018222 | Desmoid Tumors |
| ID | Term |
|---|---|
| D005350 | Fibroma |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
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| OTHER |
| Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo | OTHER |
| Erasmus University Rotterdam | OTHER |
| Istituto Oncologico Veneto IRCCS | OTHER |
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| Azienda Ospedaliero Universitaria Careggi | Not yet recruiting | Florence | Italy |
|
| Azienda Usl Toscana centro | Not yet recruiting | Florence | Italy |
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| Fondazione IRCCS Istituto Nazionale dei Tumori | Recruiting | Milan | 20133 | Italy |
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| IRCCS Istituto Oncologico Veneto IOV | Not yet recruiting | Padova | Italy |
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| Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone" | Not yet recruiting | Palermo | Italy |
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| Università Campus Bio-Medico | Not yet recruiting | Rome | Italy |
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| Erasmus University Medical Centre | Not yet recruiting | Rotterdam | Netherlands |
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| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |