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

Sponsor
European Institute of Oncology
Study ID
NCT07815873
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • sample collection — BIOLOGICAL
    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.

Study Details

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.

Key Dates

First listed
Sep 11, 2026
Start date
Oct 1, 2026
Status verified
Jul 2026
Primary completion
Oct 1, 2027
Completion
Apr 1, 2031

Study Design

Enrollment
360 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Biological Sample collection
    Biological Sample

Primary Outcome Measure

Primary Endopoint [ Time Frame: 1 year ]

Central Contacts

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