Clinical trial · Observational
Tumor Immunotherapy and Microbiome Analysis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Advanced Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Subjects with advanced solid tumors starting immunotherapy
- description
- Subjects with advanced solid tumors planned to initiate standard of care immune checkpoint inhibitors
- label
- Subjects with advanced solid tumors receiving ICIs
- description
- Subjects with advanced solid tumors already receiving standard of care immune checkpoint inhibitors
Primary outcomes (2)
- measure
- Relative abundance and composition of immunotherapy response-associated bacterial species in patients with advanced/unresectable or metastatic solid tumors
- timeFrame
- 6 months
- description
- Fecal microbial composition analyzed by 16S rRNA and metagenomic sequencing
- measure
- Relative abundance and composition of immunotherapy toxicity-associated bacterial species in patients with advanced/unresectable or metastatic solid tumors
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available