Clinical trial · Observational
Immunological Phenotype of Desmoid-fibromatosis-affected Patients.
Immunological Profile of Patients With Desmoid-type Fibromatosis Under Active Surveillance.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Desmoid-Type Fibromatosis | Desmoid Fibromatosis | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Patients under active surveillance
- description
- Patients with primary sporadic desmoid-type fibromatosis with measurable disease
- label
- Patients receiving systemic treatment
- description
- Patients with primary sporadic desmoid-type fibromatosis with measurable disease.
Primary outcomes (4)
- measure
- Levels of circulating tumor DNA (ctDNA)
- timeFrame
- Baseline and every 3 months during the first year, then every 6 months up to 36 months.
- description
- 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).
- measure
- Phenotypic profile of circulating immune cells
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available