Understanding immunE-related toXicities by multifACeT Profiling (EXACT)

EXACT - 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.

Study Overview

• Status: Recruiting
• Conditions: Oncology

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Laura Boddy; Phone Number: 020 7352 8171; Email: exact@rmh.nhs.uk
• Study Contact Backup: Name: Arjun Modi; Email: exact@rmh.nhs.uk

Study Locations

• United Kingdom
  • London
    • Chelsea, London, United Kingdom, SW3 6JJ
      • Recruiting
      • Royal Marsden NHS Foundation Trust
      • Contact: Dilruba Kabir; Phone Number: 02073528171; Email: dilruba.kabir@rmh.nhs.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study aims to enroll and obtain samples of investigational interest from 200 patients with a confirmed diagnosis of any form of solid malignancy with a clinical indication and appropriate treatment plan to commence immune checkpoint inhibitor therapy.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patients who experience irAEs	To determine the proportion of patients who experience irAEs during treatment with CPI.	36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biological and clinical characteristics	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).	60 months
Time to development of irAEs	To determine time to clinical development of irAEs during treatment with CPI.	36 months
Proportion of patients experiencing irAEs	• To determine the proportion of patients experiencing any irAE during long-term follow up, post treatment.	60 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on patients quality of life using patient questionnaires	• Explore the quality-of-life impact on patients enrolled in longitudinal multi-facet disease profiling and in patients who develop irAEs.	60 months

Collaborators and Investigators

• Sponsor: Royal Marsden NHS Foundation Trust
• Investigators: Principal Investigator: Samra Turajlic, Royal Marsden NHS Foundation Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 6, 2022
• Primary Completion (Estimated): April 6, 2028
• Study Completion (Estimated): April 6, 2028

Study Registration Dates

• First Submitted: April 8, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 5064

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No