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NCT04107311: INSPECT-IO
Prospective Analysis of Intestinal Microbiome and Autoimmune Panels as Predictors of Toxicity in ImmunOncology Patients
trial in Solid Tumor in 120 participants. Currently enrolling.
5 March 2026
Quick facts
| Lead sponsor | University Health Network, Toronto |
|---|---|
| Status | Recruiting now |
| Study type | OBSERVATIONAL |
| Enrollment | 120 |
| Start date | 5 September 2019 |
| Primary completion | 5 March 2026 |
| Estimated completion | 5 March 2026 |
| Sites | 1 location across Canada |
Conditions studied
- Solid Tumor — all drugs for Solid Tumor →
Sponsor
University Health Network, Toronto
Who can join
18 and older, any sex, with Solid Tumor. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
6 peer-reviewed publications reference this trial (live from Europe PMC):
-
Immune-related adverse events and the balancing act of immunotherapy.
Conroy M, Naidoo J. · · 2022 · cited 253× · PMID 35046403 · DOI 10.1038/s41467-022-27960-2 -
Holistic Approach to Immune Checkpoint Inhibitor-Related Adverse Events.
Poto R, Troiani T, Criscuolo G, Marone G, et al · · 2022 · cited 95× · PMID 35432346 · DOI 10.3389/fimmu.2022.804597 -
Reprogramming the breast tumor immune microenvironment: cold-to-hot transition for enhanced immunotherapy.
Imani S, Farghadani R, Roozitalab G, Maghsoudloo M, et al · · 2025 · cited 41× · PMID 40281554 · DOI 10.1186/s13046-025-03394-8 -
Monitoring and Modulating Diet and Gut Microbes to Enhance Response and Reduce Toxicity to Cancer Treatment.
Knisely A, Seo YD, Wargo JA, Chelvanambi M. · · 2023 · cited 14× · PMID 36765735 · DOI 10.3390/cancers15030777 -
Autoimmune PaneLs as PrEdictors of Toxicity in Patients TReated with Immune Checkpoint InhibiTors (ALERT).
Genta S, Lajkosz K, Yee NR, Spiliopoulou P, et al · · 2023 · cited 8× · PMID 37865776 · DOI 10.1186/s13046-023-02851-6 -
The multifaceted roles of common gut microbiota in immune checkpoint inhibitor-mediated colitis: From mechanism to clinical application.
Han X, Zang D, Liu D, Chen J. · · 2022 · cited 8× · PMID 36189293 · DOI 10.3389/fimmu.2022.988849
Verify or expand the search:
- PubMed search for NCT04107311
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Solid Tumor
Currently open trials in the same condition.
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- NCT07487597 — Functionally Enhanced ALPP-Targeted Engineered T Cells in Advanced Solid Tumors · EARLY_PHASE1 · recruiting
- NCT07382544 — Phase 1b Trial of BMS-986504 in Combination With Olaparib in Patients With MTAP Loss · Phase 1 · recruiting
- NCT07466160 — A Phase Ib/II Study of 7MW3711 Combined With JS207 in Advanced Solid Tumors · Phase 1, PHASE2 · recruiting
- NCT07450560 — Research on Real-time Proton Therapy Guidance Through Monitoring Proton Range Using All-digital PET · active not recruiting
Other University Health Network, Toronto trials
Trials by the same sponsor.
- NCT06831032 — Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response · NA · recruiting
- NCT06634056 — Pneumonitis Prevention Protocol Using Pentoxifylline and α-tocopherol In Stage III Non-Small Cell Lung Cancer Patients U · Phase 2 · not yet recruiting
- NCT06836726 — Clinical Trial to Test Efficacy of Targeting Hypoxia Combined With ARSI After First-line ARSI Therapy for Castrate Resis · Phase 2 · not yet recruiting
- NCT07515651 — Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas · Phase 2 · not yet recruiting
- NCT07509450 — Fecal Microbiota Transplantation in Patients Undergoing Chimeric Antigen Receptor T-cell Therapy and Allogeneic Stem Cel · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04107311 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by University Health Network, Toronto
- Last refreshed: 2 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04107311.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing