Advanced Solid TumorTIMENCT04579978
Tumor Immunotherapy and Microbiome Analysis
An observational study of Advanced Solid Tumor, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Solid Tumor
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- 1 Apr 2018to Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Subjects with a history of inflammatory bowel disease, chronic diarrhea or malabsorption syndromes and significant prior bowel resection as judged by the study investigator
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario, M4N 3M5
Rossanna C. Pezo, MD/PhD, 416-480-4757, rossanna.pezo@sunnybrook.ca
About this study
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.
Read the 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.
- Conditions
- Advanced Solid Tumor
- Keywords
- Immune Checkpoint Inhibitor, Microbiome, Immune-Mediated Toxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relative abundance and composition of immunotherapy response-associated bacterial species in patients with advanced/unresectable or metastatic solid tumors
Fecal microbial composition analyzed by 16S rRNA and metagenomic sequencing
Measured: 6 months
Relative abundance and composition of immunotherapy toxicity-associated bacterial species in patients with advanced/unresectable or metastatic solid tumors
Fecal microbial composition analyzed by 16S rRNA and metagenomic sequencing; IgA sequencing of fecal samples from patients who develop diarrhea/colitis
Measured: 12 months
Secondary outcomes (4)
Changes in the composition of the intestinal microbiome induced by ICIs
Fecal microbial composition analyzed by 16S rRNA and metagenomic sequencing
Measured: 6 months
Relative abundance of bacterial DNA in peripheral blood samples
Blood microbial abundance measured via qPCR
Measured: 6 months
Changes in immune cell subsets in the systemic circulation upon progression on ICIs correlated with changes in microbiome composition
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
Measured: 2 years
Identification of serum metabolites in systemic circulation and correlation with intestinal microbiome composition
Analysis of serum metabolites using chromatography coupled to tandem mass spectrometry
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2020
- Study start1 Apr 2018
- Primary completionDec 2023 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada, University of Toronto
- Responsible party
- Sponsor
- Investigators
- Rossanna C. Pezo, MD/PhD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04579978
- Sponsor's protocol ID
- TIME
- Acronym
- TIME
- Status last verified
- May 2022
- First submitted
- 1 Oct 2020
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tumor Immunotherapy and Microbiome Analysis
- ClinicalTrials.gov ID
- NCT04579978
- Acronym / sponsor ID
- TIME / TIME
- Conditions
- Advanced Solid Tumor
- Keywords
- Immune Checkpoint Inhibitor, Microbiome, Immune-Mediated Toxicity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Princess Margaret Hospital, Canada, University of Toronto
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (1 listed)
- Subjects with a history of inflammatory bowel disease, chronic diarrhea or malabsorption syndromes and significant prior bowel resection as judged by the study investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
4 secondary outcomes
Changes in the composition of the intestinal microbiome induced by ICIs
Time frame: 6 months
Relative abundance of bacterial DNA in peripheral blood samples
Time frame: 6 months
Changes in immune cell subsets in the systemic circulation upon progression on ICIs correlated with changes in microbiome composition
Time frame: 2 years
Identification of serum metabolites in systemic circulation and correlation with intestinal microbiome composition
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rossanna C. Pezo, MD/PhD principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Advanced Solid Tumor, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rossanna C. Pezo, MD/PhD (416-480-4757, rossanna.pezo@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.