Actively Recruiting

Age: 18Years - 90Years
All Genders
Healthy Volunteers
ID05621837

Quantifying Systemic Immunosuppression to Personalize Cancer Therapy

Led by Fondazione IRCCS Istituto Nazionale dei Tumori, Milano · Updated on 2025-05-02

1000

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

The research project called Serpentine focuses on measuring a specific type of immune cell called Myeloid-derived Suppressor Cells (MDSC) in blood to help personalize cancer treatments. It aims to translate this measurement into clinical practice by using a special test that can be applied to different cancer patients. The study also explores new related biomarkers and potential drugs to block MDSCs, and investigates the link between social isolation and immune changes in cancer progression. Participants include patients with various cancers such as metastatic melanoma, hormone receptor-positive breast cancer, advanced renal cell carcinoma, urothelial carcinoma, squamous cell carcinomas of head and neck, small cell carcinoma, and non-small cell lung cancer. Healthy volunteers matched by age and gender will also join to provide baseline immune data. Blood samples will be collected at the start and during treatment, with optional samples if the disease progresses. During the study, participants will have blood tests to measure immune cells before treatment, around one month, and after about three months, continuing for an average of two years. Researchers will assess clinical outcomes like progression-free survival, overall survival, and response rate. Additional evaluations include molecular and metabolic profiles and socio-economic-psychological surveys. The study involves regular follow-up visits to monitor immune status and treatment effects over time.

CONDITIONS

Brief Title

Quantifying Systemic Immunosuppression to Personalize Cancer Therapy

Who Can Participate

Age: 18Years - 90Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Histologically documented diagnosis of metastatic or locally advanced melanoma, hormone-refractory breast cancer, renal cell carcinoma, urothelial carcinoma, squamous cell carcinoma of head and neck, small cell carcinoma, or non-small cell lung cancer, including stage III resectable NSCLC
  • Willingness and ability to comply with the study protocol
  • Willingness and ability to provide an adequate archival tumor sample for biomarker analysis
  • Age between 18 and 90 years at time of recruitment
  • ECOG Performance Status of 2 or less
  • Ability to understand and sign informed consent
  • Agreement to participate in socio-economic and psychological surveys
Not Eligible

You will not qualify if you...

  • Known history of HIV infection
  • Serious neurological or psychiatric disorders
  • Pregnancy or lactation
  • Inability or unwillingness to provide written informed consent
  • Inability or unwillingness to be regularly followed up at the same center

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Sample Collection

Duration - Up to 2 years

Participants provide blood samples at baseline, during therapy, and optionally if disease progression occurs to quantify Myeloid-derived Suppressor Cells (MDSC) and analyze related biomarkers.

3 visits spaced around baseline, one month, and three months, plus additional visits through study completion

Long-term Monitoring

Duration - Up to 2 years

Participants are monitored for immunological, clinical, and socio-economic outcomes related to cancer therapy and systemic immunosuppression.

Regular assessments through study completion

Trial Site Locations

Total: 1 location

1

Fondazione IRCCS Istituto Nazionale dei Tumori

Milan, Italy, 20033

Actively Recruiting

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Research Team

L

Licia Rivoltini

P

Paola Frati

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

6

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Published Research Related To This Trial

Molecular interactions between dying tumor cells and the innate immune system determine the efficacy of conventional anticancer therapies.

Lionel Apetoh, Antoine Tesniere, François Ghiringhelli...

https://pubmed.ncbi.nlm.nih.gov/18519658

High numbers of differentiated effector CD4 T cells are found in patients with cancer and correlate with clinical response after neoadjuvant therapy of breast cancer.

Isabelle Péguillet, Maud Milder, Delphine Louis...

https://pubmed.ncbi.nlm.nih.gov/24535711

Myeloid Cells That Impair Immunotherapy Are Restored in Melanomas with Acquired Resistance to BRAF Inhibitors.

Shannon M Steinberg, Tamer B Shabaneh, Peisheng Zhang...

https://pubmed.ncbi.nlm.nih.gov/28202513