STRICT - Surveillance With TRoponin During Immune Checkpoint Therapy

Conditions

• Immune Checkpoint Therapy

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Troponin surveillance — DIAGNOSTIC_TEST
  Troponin will be monitored prior to each immune checkpoint inhibitor infusion for the first 12 weeks of therapy.
• Standard of care — OTHER
  Standard of care if symptoms arise then evaluation with cardiac biomarkers and/or further cardiac testing.

Study Details

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.

Key Dates

Start date

Feb 2, 2024

Status verified

Jan 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2028

Study Design

Enrollment

980 participants (estimated)

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Arms

• Experimental: Troponin Surveillance
  Participants in Group 1, will have blood tests performed prior to each immune checkpoint inhibitor infusion for 12 weeks.
• Experimental: Standard of Care
  Participants in Group 2, will have standard of care testing for any heart-related side effects of immune checkpoint inhibitors.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

• Nicolas Palaskas, MD
  (713) 606-3957
  [email protected]

Locations (1)

Find similar trials in Houston, TX

Related Studies

• A Prospective Real World Evidence Study (PROWES) for Concordance Rate of Blood-based 3D Genome Conformation Mapping (Episwitch CiRT®) to Identify Likelihood of Response and Actual Response Rates to PD-(L)-1 Checkpoint Inhibitors Across Multiple Oncological Indications.
  Recruiting · Oxford Biodynamics Inc. · Norwich, Connecticut