Healthy Clinical Trial
— SERPENTINEOfficial title:
Quantifying Systemic Immunosuppression to Personalize Cancer Therapy
Verified date | December 2022 |
Source | Institut du Cancer de Montpellier - Val d'Aurelle |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
It is nowadays well established that the immune system can profoundly influence disease outcome in cancer patients. Increasing evidence is indeed showing that patients displaying spontaneous T cell-mediated immune response against their tumor (defined as immune surveillance) have higher chance to respond to therapies and display globally better prognosis. Conversely, patients whose tumor is characterized by immunosuppression, usually involving myeloid cells and chronic inflammation pathways, often undergo rapid progression and rarely benefit from therapy. Hence, capturing the immune features of individual tumors can help to predict disease course and tailor the therapeutic workup in clinical setting.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | March 2024 |
Est. primary completion date | March 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 90 Years |
Eligibility | Inclusion Criteria: - Histologically 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 included - Will and ability to comply with the protocol - Willingness and ability to provide an adequate archival Formalin- Fixed Paraffin-Embedded (FFPE) tumor sample available for exploratory biomarker analysis - Age from 18 to 90 years at the time of recruitment - ECOG Performance Status < 2 - Understanding and signature of the informed consent Exclusion Criteria: - Known history of HIV infection - Serious neurological or psychiatric disorders - Pregnancy or lactation - Inability or unwillingness of participant to give written informed consent - Inability or unwillingness to be regularly followed up at the enrolling center |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Institut du Cancer de Montpellier - Val d'Aurelle | Fondazione IRCCS ISTITUTO NAZIONALE TUMORI |
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* Note: There are 23 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Investigation of whether a flow cytometry blood-based MDSC quantification assay, does predict disease course in different cancer patients undergoing standard therapies including immunotherapy, chemotherapy, target therapies and surgery. | Correlation of myeloid-related blood biomarkers (including quantification of myeloid cell subsets in peripheral blood mononuclear cells and whole blood) with disease outcome including objective response to therapy, progression-free survival and overall survival, to identify tool for predicting resistance to treatment and poor prognosis. | during 3 months after the start of the treatment | |
Secondary | discovery and development of an additional MDSC-related blood biomarkers associated with the phenotypic or functional profile of these cells | Transcriptional signatures identified on PBMC and sorted myeloid cells form whole blood, at baseline or first evaluation | during 3 months after the start of the treatment | |
Secondary | obtention insights into the signaling and metabolic pathways regulating human MDSC, for the discovery of innovative cancer therapeutic targets based on immunomodulation | Metabolomic profiles, as defined by the concentration of individual metabolites or cluster of metabolites implicated in amino acid and lipid metabolism | during 3 months after the start of the treatment | |
Secondary | perform the first survey assessing the link between MDSC (myeloid-derived suppressor cells) immunosuppression and patient psychological traits, including socio-economical status and perceived social isolation | Loneliness Questionnaire (no min and max values) | at the baseline | |
Secondary | perform the first survey assessing the link between MDSC (myeloid-derived suppressor cells) immunosuppression and patient psychological traits, including socio-economical status and perceived social isolation | Socio-Economical Questionnaire (no min and max values) | at the baseline |
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