Ignite Creation Date:
2025-12-24 @ 4:12 PM
Ignite Modification Date:
2026-01-01 @ 5:25 PM
Study NCT ID:
NCT05331066
Status:
RECRUITING
Last Update Posted:
2025-10-01
First Post:
2022-04-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Understanding immunE-related toXicities by multifACeT Profiling
Sponsor:
Royal Marsden NHS Foundation Trust
Organization:
Study Overview
Official Title:
EXACT - Understanding immunE-related toXicities by multifACeT Profiling
Status:
RECRUITING
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EXACT
Brief Summary:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: