Clinical trial · Observational
Prospective Analysis of Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in ImmunOncology Patients
- 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)
This is a single-center, investigator-initiated, non-interventional study evaluating the role of the intestinal microbiome and autoimmune panels as a predictor for developing ≥ Grade 2 CTCAE v5.0 immune-related adverse event (irAE) and/or requiring systemic immunosuppression for irAEs in advanced solid tumor patients receiving immunooncology (IO) combinations at the Princess Margaret Cancer Centre. This is a minimal risk study involving the analysis of patient samples and does not involve therapeutic intervention. The study will involve a prospective cohort of up to 120 patients and it is anticipated that patient accrual will be completed within 18 months. Patients will receive IO combination as per their specific protocols from their other clinical trial or per their standard of care and samples will be collected at multiple time-points. No additional visits to the hospital will be needed for this study as safety assessments are already captured for all patients based on their participation in a clinical trial or per their standard of care.
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 |
|---|---|---|---|
| Solid Tumor | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Feasibility of evaluating intestinal microbiome composition and autoimmune panels in patients treated with immunooncology combinations through the analysis of stool and blood samples at multiple time-points.
- timeFrame
- 18 months
- description
- To assess the feasibility, the endpoint will be deemed feasible if \>50% of patients have biospecimens collected in at least 2 time-points.
Secondary outcomes (7)
- measure
- Correlation between baseline intestinal microbiome composition to the development of ≥ Grade 2 CTCAE v5.0 irAEs and/or requiring systemic immunosuppression for irAEs.
- timeFrame
- 18 months
- description
- Correlation between bacteria taxa obtained through 16S rRNA sequencing and irAEs.
- measure
- Correlation between baseline autoimmune panels to the development of ≥ Grade 2 CTCAE v5.0 irAEs and/or requiring systemic immunosuppression for irAEs.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Signed written and voluntary informed consent. 2. Patient must be willing and able to provide collection for blood and stool specimen analysis at the pre-specified time-points. 3. Age \> 18 years, male or female. 4. Patient must be diagnosed with any advanced solid tumor deemed incurable and to be treated at Princess Margaret Cancer Centre. 5. Patients must be eligible to treatment with an IO combination. Exclusion Criteria: 1. Any conditions that in the opinion of the Investigator would interfere with patient safety, or evaluation of the collected specimen and interpretation of study result. 2. History of autoimmune disease with a flare episode within one year before study screening.
References
Publications (1)
- DERIVEDGenta S, Lajkosz K, Yee NR, Spiliopoulou P, Heirali A, Hansen AR, Siu LL, Saibil S, Stayner LA, Yanekina M, Sauder MB, Keshavarzi S, Salawu A, Vornicova O, Butler MO, Bedard PL, Razak ARA, Rottapel R, Chruscinski A, Coburn B, Spreafico A. Autoimmune PaneLs as PrEdictors of Toxicity in Patients TReated with Immune Checkpoint InhibiTors (ALERT). J Exp Clin Cancer Res. 2023 Oct 21;42(1):276. doi: 10.1186/s13046-023-02851-6. PMID 37865776