Personalizing cancer therapy by measuring immune suppression
Official title: Quantifying Systemic Immunosuppression to Personalize Cancer Therapy
Run by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · NCT05621837 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 90 Years |
| Sex | All |
| Enrollment | 1000 (estimated) |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano Academic / other |
| Locations | 1 site (Milan) |
| Status | Recruiting |
| Started | March 10, 2022 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | May 2, 2025 |
| Trial ID | NCT05621837 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably 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.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the quantification of MDSC in clinical practice is a novel approach, similar studies have shown promise in understanding immune suppression in cancer.
Who can join: the full rules
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 it's running
-
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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.