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NCT Number: NCT05331066

Understanding immunE-related toXicities by multifACeT Profiling

A prospective observational cohort study of patients undergoing CPI therapy in which translational research is the fundamental aspect of the study.

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Key information

Conditions

Oncology Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Marsden NHS Foundation Trust

Chelsea, London, SW3 6JJ, United Kingdom

Location status: Recruiting

About this study

The study aims to enroll and obtain samples of investigational interest from 200 patients over a 36-month recruitment period. Blood and/ or stool samples will be taken at baseline, in context of irAE development / during CPI treatment and during follow-up. Skin samples may also be taken upon development of organspeciifc irAEs.

Further assessments at baseline or during the course of or following treatment will be conducted in accordance with standard institutional practice and will be clinically driven. Clinical data, samples and results from archival, current or prospective diagnostic or therapeutic procedures will be used for research purposes within EXACT.

IrAE clinical monitoring will be conducted in accordance with standard institutional practice and will be clinically driven.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Patients who experience irAEs

    Time frame: 36 months

    To determine the proportion of patients who experience irAEs during treatment with CPI.

Secondary outcomes

  1. Biological and clinical characteristics

    Time frame: 60 months

    To profile biological and clinical characteristics at baseline and during treatment with CPI to detect indicators predictive of the development of immunotherapy-related adverse events (irAEs).

  2. Time to development of irAEs

    Time frame: 36 months

    To determine time to clinical development of irAEs during treatment with CPI.

  3. Proportion of patients experiencing irAEs

    Time frame: 60 months

    • To determine the proportion of patients experiencing any irAE during long-term follow up, post treatment.

Other outcomes

  1. Impact on patients quality of life using patient questionnaires

    Time frame: 60 months

    • Explore the quality-of-life impact on patients enrolled in longitudinal multi-facet disease profiling and in patients who develop irAEs.

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

Royal Marsden NHS Foundation Trust

Other

Registry information

Official study title

EXACT - Understanding immunE-related toXicities by multifACeT Profiling

Acronym: EXACT

Important dates

Study start
2022
Primary completion
2028
Study completion
2028
First posted
Apr 15, 2022
Registry last updated
Oct 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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