Understanding immune-related toxicities in cancer patients receiving therapy
Official title: EXACT - Understanding immunE-related toXicities by multifACeT Profiling
Run by Royal Marsden NHS Foundation Trust · NCT05331066 · Data updated 2026-11-12
This study is trying to learn more about the side effects that cancer patients may experience while receiving a new type of treatment called immune checkpoint inhibitors.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Royal Marsden NHS Foundation Trust Academic / other |
| Locations | 1 site (Chelsea, London) |
| Status | Recruiting |
| Started | April 6, 2022 |
| Main results expected | April 6, 2028 |
| Study ends | April 6, 2028 |
| Registry record updated | October 1, 2025 |
| Trial ID | NCT05331066 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults aged 18 and older with a confirmed diagnosis of any solid tumor who are about to start immune checkpoint inhibitor therapy.
✕Probably not a fit
Patients with medical or psychological conditions that prevent informed consent or those already receiving immune checkpoint inhibitors will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational cohort study aims to enroll 200 patients with solid malignancies who are starting immune checkpoint inhibitor therapy. It will collect blood, stool, and potentially skin samples at various stages, including baseline, during treatment, and follow-up, to investigate the development of immune-related adverse events (irAEs). The study will utilize clinical data and samples in accordance with standard practices to enhance understanding of irAEs and improve patient management. The recruitment period is set for 36 months, focusing on translational research to inform future therapeutic strategies.
Why it matters
Potential benefit: If successful, this study could lead to better management and prevention of immune-related toxicities in cancer patients undergoing treatment.
How similar studies have gone: While the approach of profiling immune-related toxicities is gaining interest, this specific study's methodology is novel and not extensively tested in prior research.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Written informed consent * Age 18 years or older * Confirmed diagnosis of any form of solid malignancy with a clinical indication and appropriate treatment plan to commence immune checkpoint inhibitor therapy Exclusion Criteria: * Medical or psychological condition that would preclude informed consent * Planned participation in a drug trial receiving investigational agents * Subjects who have previously commenced immune checkpoint inhibitor therapy prior to study entry. * Subjects unable to comply with the study or sample schedule.
Where it's running
-
Royal Marsden NHS Foundation Trust
Chelsea, London, United Kingdom Recruiting
Study contacts
- Principal investigator: Samra Turajlic — Royal Marsden NHS Foundation Trust
- Study coordinator: Laura Boddy
- Email: exact@rmh.nhs.uk
- Phone: 020 7352 8171
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.