Quantifying Systemic Immunosuppression to Personalize Cancer Therapy

Trial Title: Quantifying Systemic Immunosuppression to Personalize Cancer Therapy

NCT ID: NCT05621837

Condition: Melanoma
Breast Cancer
Renal Cell Carcinoma
Urinary Bladder Cancer
Squamous Cell Carcinoma of Head and Neck
Small Cell Carcinoma
NSCLC

Conditions: Official terms:
Carcinoma
Urinary Bladder Neoplasms
Carcinoma, Renal Cell
Squamous Cell Carcinoma of Head and Neck
Carcinoma, Small Cell
Small Cell Lung Carcinoma

Study type: Observational

Overall status: Recruiting

Study design:

Time perspective: Prospective

Intervention:

Intervention type: Other
Intervention name: MDSC quantification
Description: Blood sample will be collected at baseline and during therapy, and, optionally, in case of disease progression (PD).
Arm group label: Advanced RCC(renal cell carcinoma) patients
Arm group label: Age and gender-matched healthy donors
Arm group label: Metastatic melanoma patients
Arm group label: NSCLC patients
Arm group label: SCCHN or SCC(Small Cell Carcinoma) patients
Arm group label: hormone receptor positive/Human Epidermal growth factor Receptor-2 negative cancer patients

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.

Detailed description: The study will demonstrate that this assay helps personalizing cancer therapies by tailoring them to immune patient features. The project will also take advantage of innovative and high-throughput techniques to define additional MDSC related biomarkers and, most importantly, to identify novel drugs for Myeloid-derived Suppressor Cells (MDSC) blocking in predisposed patients. Finally,it will perform the first survey assessing the link between MDSC and "perceived social isolation", an emerging western social problem recently shown to cause myeloid cell dysfunction and immunosuppression though neuroendocrine circuits. Globally, the Serpentine proposal has the ambitious goal to translate into the clinical oncological practise the use of MDSC quantification as a tool for the systematic assessment of systemic immunosuppression, providing at the same time operational insights into the strategies to overcome this pillar mechanism of cancer progression.

Criteria for eligibility:

Study pop:
Patients with five diverse tumor histotypes (n=600) will be collected in parallel clinical case-sets, with power calculation estimated on the basis of MIS validation in melanoma (n=100 patients per histotypes, with the exception of the 200 patients to be enrolled for NSCLC). In addition, a group of age and gender-matched healthy donors (n=400) will be also included to provide normal values of the myeloid-related parameters under physiological conditions.

Sampling method: Probability Sample
Criteria:
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 - Consenting to participate to the socio-economical-psychological survey 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 same center

Gender: All

Minimum age: 18 Years

Maximum age: 90 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: Fondazione IRCCS Istituto Nazionale dei Tumori

Address:
City: Milan
Zip: 20033
Country: Italy

Status: Recruiting

Contact:
Last name: Licia Rivoltini, MD

Phone: +3902/23903245
Email: licia.rivoltini@istitutotumori.mi.it

Contact backup:
Last name: Paola Frati

Phone: +3902/23903036
Email: paola.frati@istitutotumori.mi.it

Start date: March 10, 2022

Completion date: February 28, 2025

Lead sponsor:
Agency: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
Agency class: Other

Source: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05621837