Understanding immunE-related toXicities by multifACeT Profiling

NCT ID: NCT05331066

Last Updated: 2025-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-06

Study Completion Date

2028-04-06

Brief Summary

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

Detailed Description

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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.

Conditions

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Oncology

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Royal Marsden NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Samra Turajlic

Role: PRINCIPAL_INVESTIGATOR

Royal Marsden NHS Foundation Trust

Locations

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Royal Marsden NHS Foundation Trust

Chelsea, London, United Kingdom

Site Status RECRUITING

Countries

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United Kingdom

Central Contacts

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Laura Boddy

Role: CONTACT

020 7352 8171

Arjun Modi

Role: CONTACT

Facility Contacts

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Dilruba Kabir

Role: primary

02073528171

Other Identifiers

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5064

Identifier Type: -

Identifier Source: org_study_id

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