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EXACT: Understanding immunE-related toXicities by multifACeT Profiling

Sponsor
Royal Marsden NHS Foundation Trust (Other)
Overall Status
Recruiting
CT.gov ID
NCT05331066
Collaborator
(none)
200
Enrollment
1
Location
72
Anticipated Duration (Months)
2.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Other
    Time Perspective:
    Prospective
    Official Title:
    EXACT - Understanding immunE-related toXicities by multifACeT Profiling
    Actual Study Start Date :
    Apr 6, 2022
    Anticipated Primary Completion Date :
    Apr 6, 2028
    Anticipated Study Completion Date :
    Apr 6, 2028

    Outcome Measures

    Primary Outcome Measures

    1. Patients who experience irAEs [36 months]

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

    Secondary Outcome Measures

    1. Biological and clinical characteristics [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 [36 months]

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

    3. Proportion of patients experiencing irAEs [60 months]

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

    Other Outcome Measures

    1. Impact on patients quality of life using patient questionnaires [60 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Royal Marsden NHS Foundation Trust Chelsea London United Kingdom SW3 6JJ

    Sponsors and Collaborators

    • Royal Marsden NHS Foundation Trust

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Royal Marsden NHS Foundation Trust
    ClinicalTrials.gov Identifier:
    NCT05331066
    Other Study ID Numbers:
    • 5064
    First Posted:
    Apr 15, 2022
    Last Update Posted:
    Apr 28, 2022
    Last Verified:
    Apr 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Neoplasms

    Study Results

    No Results Posted as of Apr 28, 2022