Recruiting

Gut Microbiome

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT04579978

Conditions

Advanced Solid Tumor

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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

Advanced Solid Tumor

Study ID

NCT04579978

Start date

Apr 1, 2018

Status verified date

May, 2022

Completion date

Dec, 2024

Anticipated

Primary completion date

Dec, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not 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

Study Design

Enrollment

60 participants

Anticipated

Interventions and Outcome Measures

Arms

Subjects with advanced solid tumors starting immunotherapy

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

Subjects with advanced solid tumors receiving ICIs

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

Primary outcome measure

  • Relative abundance and composition of immunotherapy response-associated bacterial species in patients with advanced/unresectable or metastatic solid tumors [ Time Frame: 6 months ]
  • Relative abundance and composition of immunotherapy toxicity-associated bacterial species in patients with advanced/unresectable or metastatic solid tumors [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Rossanna C. Pezo, MD/PhD

416-480-4757rossanna.pezo@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

Contacts

Rossanna C. Pezo, MD/PhD

416-480-4757rossanna.pezo@sunnybrook.ca

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

May 5, 2022

Last verified

May, 2022

Keywords

  • Immune Checkpoint Inhibitor
  • Microbiome
  • Immune-Mediated Toxicity

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2022-05-05.