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Tumor Immunotherapy and Microbiome Analysis (TIME)

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ClinicalTrials.gov Identifier: NCT04579978
Recruitment Status : Recruiting
First Posted : October 8, 2020
Last Update Posted : October 8, 2020
Sponsor:
Collaborators:
Princess Margaret Hospital, Canada
University of Toronto
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre

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.

Condition or disease
Advanced Solid Tumor

Detailed Description:
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.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Tumor Immunotherapy and Microbiome Analysis
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Group/Cohort
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 Measures :
  1. Relative abundance and composition of immunotherapy response-associated bacterial species in patients with advanced/unresectable or metastatic solid tumors [ Time Frame: 6 months ]
    Fecal microbial composition analyzed by 16S rRNA and metagenomic sequencing

  2. Relative abundance and composition of immunotherapy toxicity-associated bacterial species in patients with advanced/unresectable or metastatic solid tumors [ Time Frame: 12 months ]
    Fecal microbial composition analyzed by 16S rRNA and metagenomic sequencing; IgA sequencing of fecal samples from patients who develop diarrhea/colitis


Secondary Outcome Measures :
  1. Changes in the composition of the intestinal microbiome induced by ICIs [ Time Frame: 6 months ]
    Fecal microbial composition analyzed by 16S rRNA and metagenomic sequencing

  2. Relative abundance of bacterial DNA in peripheral blood samples [ Time Frame: 6 months ]
    Blood microbial abundance measured via qPCR

  3. Changes in immune cell subsets in the systemic circulation upon progression on ICIs correlated with changes in microbiome composition [ Time Frame: 2 years ]
    Flow cytometry of blood at baseline and at development of progressive disease and analysis of microbiome composition at baseline and at development of progressive disease

  4. Identification of serum metabolites in systemic circulation and correlation with intestinal microbiome composition [ Time Frame: 6 months ]
    Analysis of serum metabolites using chromatography coupled to tandem mass spectrometry


Biospecimen Retention:   Samples With DNA
Fecal samples will be collected for analysis of gut bacteria. Peripheral blood samples will be collected via phlebotomy for analysis of immune markers and circulating bacteria.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Adult patients with advanced/unresectable or metastatic solid tumors either planned to start standard of care treatment with ICIs or already on treatment with ICIs.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04579978


Contacts
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Contact: Rossanna C. Pezo, MD/PhD 416-480-4757 rossanna.pezo@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Rossanna C. Pezo, MD/PhD    416-480-4757    rossanna.pezo@sunnybrook.ca   
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Princess Margaret Hospital, Canada
University of Toronto
Investigators
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Principal Investigator: Rossanna C. Pezo, MD/PhD Sunnybrook Health Sciences Centre
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Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT04579978    
Other Study ID Numbers: TIME
First Posted: October 8, 2020    Key Record Dates
Last Update Posted: October 8, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sunnybrook Health Sciences Centre:
Immune Checkpoint Inhibitor
Microbiome
Immune-Mediated Toxicity