Decoupling Immunotherapy Toxicity and Cancer Response
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorM.D. Anderson Cancer Center
About this trial
This study is a novel evaluation of cardiotoxicity after ICI therapy based on traditional CV risk factors with the addition of metabolomic profiles, epigenetic aging, and CHIP. It is not an extension of previous work in ICI therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Plan to start immune checkpoint inhibitor for cancer therapy
Disqualifiers
No baseline blood collection prior to initiation
At time of evaluation not determined to be a good candidate for evaluation of outcome events by the principal investigator
Trial population
MD Anderson Cancer Center
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
1,200 Participants
are grouped into 1 trial groupGroup A: Prospective Observational Cohort
Trial outcomes
Primary outcomes
1
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
Time frame
Through study completion; an average of 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov