Personalizing cancer therapy by measuring immune suppression
Quantifying Systemic Immunosuppression to Personalize Cancer Therapy
This study is testing whether measuring certain immune cells in cancer patients can help tailor their treatments and understand how feelings of isolation might affect their immune system.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | All |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Locations | 1 site (Milan) |
| Trial ID | NCT05621837 on ClinicalTrials.gov |
What this trial studies
The Serpentine project aims to translate the quantification of Myeloid-derived Suppressor Cells (MDSC) into clinical practice to personalize cancer therapies for patients with various types of cancer, including melanoma and breast cancer. This observational study will utilize a compliant assay to measure MDSC levels in peripheral blood and explore additional biomarkers related to MDSC. Furthermore, it will investigate the relationship between MDSC and perceived social isolation, which may contribute to immune dysfunction. The ultimate goal is to provide insights into overcoming systemic immunosuppression in cancer progression.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 to 90 with advanced or metastatic melanoma, breast cancer, renal cell carcinoma, urinary bladder cancer, or squamous cell carcinoma.
Not a fit: Patients with serious neurological or psychiatric disorders, or those with a known history of HIV infection, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more effective and tailored cancer treatments based on individual immune profiles.
How similar studies have performed: While the quantification of MDSC in clinical practice is a novel approach, similar studies have shown promise in understanding immune suppression in cancer.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Milan
- Fondazione IRCCS Istituto Nazionale dei Tumori — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Licia Rivoltini — Fondazione IRCCS Istituto Nazionale Tumori - Milan
- Study coordinator: Licia Rivoltini
- Email: licia.rivoltini@istitutotumori.mi.it
- Phone: +3902/23903245
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.