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.
Study Type
OBSERVATIONAL
Enrollment
200
IRCCS Istituto di Candiolo Fondazione del Piemonte per l'Oncologia
Candiolo, Italy
NOT_YET_RECRUITINGAzienda Ospedaliero Universitaria Careggi
Florence, Italy
NOT_YET_RECRUITINGAzienda Usl Toscana centro
Florence, Italy
NOT_YET_RECRUITINGFondazione IRCCS Istituto Nazionale dei Tumori
Milan, Italy
RECRUITINGIRCCS Istituto Oncologico Veneto IOV
Padova, Italy
NOT_YET_RECRUITINGAzienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
Palermo, Italy
NOT_YET_RECRUITINGUniversità Campus Bio-Medico
Rome, Italy
NOT_YET_RECRUITINGErasmus University Medical Centre
Rotterdam, Netherlands
NOT_YET_RECRUITINGLevels 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.