Tumor Immunotherapy and Microbiome Analysis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-04-01

Study Completion Date

2024-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The composition of the gut microbiome has been associated with response and the development of toxicities on immune checkpoint inhibitors (ICIs) in multiple tumor types. The aim of this study is to examine the gut microbiome composition in patients undergoing standard of care treatment for advanced/unresectable and/or metastatic solid tumors with ICIs. Fecal samples and peripheral blood samples will be collected to further characterize the diversity of gut bacteria and to study potential mechanisms by which gut bacteria impact the immune response.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Establishment of Individualized Immunotherapy Strategy and Platform Based on Changes of Intestinal Microbiota

NCT05065515

Gut Microbiota

UNKNOWN

Utilization of Microbiome as Biomarkers and Therapeutics in Immuno-Oncology

NCT04264975

Solid Carcinoma

UNKNOWN NA

The Gut Microbiome and Immunotherapy Response in Solid Cancers

NCT06050733

Cancer

RECRUITING

Gut Microbiota (GM) Biodiversity in Patients With Solid Tumors Treated With Immune Checkpoint Inhibitors (ICIs): a Monocenter Prospective Study to Identify the Interactions Between GM and ICIs

NCT07236983

Solid Tumor Cancer Treatment With Immunotherapy

ACTIVE_NOT_RECRUITING

Effect of Gut Microbiota and Its Metabolites on the Efficacy of Immunotherapy in Metastatic Colorectal Cancer

NCT06714903

Colorectal Neoplasms Malignant

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This is a prospective study of gut microbial markers. Patients with histologically confirmed advanced/unresectable or metastatic solid tumors who are planned to initiate standard of care ICIs or are undergoing standard of care treatment with ICIs will be approached for participation in the study.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Advanced Solid Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Subjects with advanced solid tumors starting immunotherapy

Subjects with advanced solid tumors planned to initiate standard of care immune checkpoint inhibitors

No interventions assigned to this group

Subjects with advanced solid tumors receiving ICIs

Subjects with advanced solid tumors already receiving standard of care immune checkpoint inhibitors

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Sign written and voluntary informed consent
* Adult patients aged \>=18, male or female
* Eastern Cooperative Group (ECOG) performance status 0-2
* Histologic diagnosis of an advanced/unresectable or metastatic solid tumor
* Measurable disease as per RECIST 1.1 criteria
* Be suitable for or receiving ICI treatment
* Prior immunotherapy allowed
* Be willing and able to provide fecal and blood specimens for analysis as per protocol

Exclusion Criteria

* Subjects with a history of inflammatory bowel disease, chronic diarrhea or malabsorption syndromes and significant prior bowel resection as judged by the study investigator

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No