Understanding immunE-related toXicities by multifACeT Profiling
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Oncology. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United Kingdom
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
EXACT - Understanding immunE-related toXicities by multifACeT Profiling
Overview
A prospective observational cohort study of patients undergoing CPI therapy in which translational research is the fundamental aspect of the study.
Detailed description
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.
Primary outcome measures
- Patients who experience irAEs [Time frame: 36 months]
Secondary outcome measures (3)
- Biological and clinical characteristics [Time frame: 60 months]
- Time to development of irAEs [Time frame: 36 months]
- Proportion of patients experiencing irAEs [Time frame: 60 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
United Kingdom · 1 center
- Royal Marsden NHS Foundation Trust — Chelsea
Identifiers
NCT: NCT05331066 · 5064