RECRUITING

STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

To learn if monitoring blood levels of heart injury (troponin levels) in cancer participants treated with immune checkpoint inhibitors will lead to decreased heart-related side effects.

Official Title

STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy

Quick Facts

Study Start:2024-02-02

Study Completion:2028-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06337097

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Male or female patient ≥18 years old * Plan for treatment with an immune checkpoint inhibitor as standard of care even if patient is also on an additional investigational cancer therapeutic * Willingness to provide informed consent	* Troponin T not available at screening or prior to randomization * Inability to comply with planned study procedures * Major adverse cardiovascular event included in the primary outcome within the 30 days prior to enrollment * Any medical condition that could interfere with, or for which the treatment might interfere with the conduct of the study or interpretation of the study results, or that would, in the opinion of the investigator, increase the risk of the participant by participating in the study * Any factors that, in the Investigator's opinion, are likely to interfere with study procedures, such as history of noncompliance with scheduled appointments.

Inclusion Criteria

Exclusion Criteria

* Male or female patient ≥18 years old
* Plan for treatment with an immune checkpoint inhibitor as standard of care even if patient is also on an additional investigational cancer therapeutic
* Willingness to provide informed consent

* Troponin T not available at screening or prior to randomization
* Inability to comply with planned study procedures
* Major adverse cardiovascular event included in the primary outcome within the 30 days prior to enrollment
* Any medical condition that could interfere with, or for which the treatment might interfere with the conduct of the study or interpretation of the study results, or that would, in the opinion of the investigator, increase the risk of the participant by participating in the study
* Any factors that, in the Investigator's opinion, are likely to interfere with study procedures, such as history of noncompliance with scheduled appointments.

Contacts and Locations

Study Contact

Nicolas Palaskas, MD

CONTACT

(713) 606-3957

nlpalaskas@mdanderson.org

Principal Investigator

Nicolas Palaskas, MD

PRINCIPAL_INVESTIGATOR

M.D. Anderson Cancer Center

Study Locations (Sites)

MD Anderson Cancer Center

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: M.D. Anderson Cancer Center

Nicolas Palaskas, MD, PRINCIPAL_INVESTIGATOR, M.D. Anderson Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-02-02

Study Completion Date2028-12-31

Study Record Updates

Study Start Date2024-02-02

Study Completion Date2028-12-31

Terms related to this study

Additional Relevant MeSH Terms

Immune Checkpoint Therapy