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NOT YET RECRUITING
NCT07815873
NA

Gut Microbiome in Patients With Lung and Melanoma Cancer and Intestinal Microbiota in Gynecologic Cancers

Sponsor: European Institute of Oncology

View on ClinicalTrials.gov

Summary

This study aims to investigate the role of the gut microbiota and its derived factors, including bacterial-associated antigens that mimic tumor-associated antigens, in predicting response to immune checkpoint inhibitor immunotherapies in patients with various types of cancer. The aim is to explore whether gut microbiota-mediated immunological modulation is specific to the tumor being treated and whether it can be used to enhance antitumor response.

Official title: Leveraging Gut Microbiome and Immune System Dynamics During Immunotherapy to Develop Biomarkers of Response in Patients With Lung and Melanoma Cancer' and 'Intestinal Microbiota Profiling in Gynecologic Cancers to Identify Response-relevant Factors During Immune Checkpoint Blockade'

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

360

Start Date

2026-10-01

Completion Date

2031-04-01

Last Updated

2026-09-11

Healthy Volunteers

No

Interventions

BIOLOGICAL

sample collection

Clinical and radiological assessment will be performed at the enrollment and every 3 +/- 1 months. Clinical information and biological samples will be collected also at 2 years from surgery or start of therapy. We plan collection of a maximum of 13 faecal and blood samples per patient (1 baseline + a maximum of 11 during treatment ± 1 disease progression, ± 10%). In addition, we expect to collect fresh stools and tissue biopsies from at least 3-5 patients per group every year, which will be dedicated to our translational studies.

Locations (1)

Istituto europeo di oncologia

Milan, MI, Italy