NCT05621837 Quantifying Systemic Immunosuppression to Personalize Cancer Therapy
| NCT ID | NCT05621837 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione IRCCS Istituto Nazionale dei Tumori, Milano |
| Condition | Melanoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2022-03-10 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2022-03-10 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Licia Rivoltini
PRINCIPAL INVESTIGATOR
Fondazione IRCCS Istituto Nazionale Tumori - Milan
Frequently Asked Questions
Who can join the NCT05621837 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Melanoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05621837 currently recruiting?
Yes, NCT05621837 is actively recruiting participants. Contact the research team at licia.rivoltini@istitutotumori.mi.it for enrollment information.
Where is the NCT05621837 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT05621837 clinical trial?
NCT05621837 is sponsored by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano. The principal investigator is Licia Rivoltini at Fondazione IRCCS Istituto Nazionale Tumori - Milan. The trial plans to enroll 1,000 participants.
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