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Recruiting
NCT05621837
Quantifying Systemic Immunosuppression to Personalize Cancer Therapy
Conditions: Melanoma, Breast Cancer, Renal Cell Carcinoma, Urinary Bladder Cancer, Squamous Cell Carcinoma of Head and Neck, Small Cell Carcinoma, NSCLC
Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: 1
Enrollment: 1000
Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Location: Italy
Summary
The Serpentine (Stratify cancER PatiENTs by ImmuNosupprEssion) project, represents the most consistent effort so far attempted to translate MDSC into clinical practise by producing an off-the-shelf compliant assay for quantifying these cells in peripheral blood.
Eligibility Criteria
Inclusion CriteriaHistologically documented diagnosis of metastatic/locally advanced melanoma, hormone-refractory breast cancer, RCC and UC, SCCHN, SCC or NSCLC, stage III resectable NSCLC will also be includedWill and ability to comply with the protocolWillingness and ability to provide an adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumor sample available for exploratory biomarker analysisAge from 18 to 90 years at the time of recruitmentECOG Performance Status <= 2Understanding and signature of the informed consentConsenting to participate to the socio-economical-psychological surveyExclusion CriteriaKnown history of HIV infectionSerious neurological or psychiatric disordersPregnancy or lactationInability or unwillingness of participant to give written informed consentInability or unwillingness to be regularly followed up at the same center
Source: ClinicalTrials.gov (NCT05621837). StuddyBuddy aggregates publicly available trial information.