Routine LDL Exam For Cancer Survivors | NCT07738250

NCT07738250

Overview

NCT ID: NCT07738250
Lead Sponsor: Samsung Medical CenterOTHER
Official Title: Association of Annual LDL Cholesterol Testing With Cardiovascular Outcomes Among Cancer Survivors: A Sequential Target Trial Emulation
Brief Summary: This observational study will evaluate whether annual low-density lipoprotein cholesterol (LDL-C) testing is associated with improved cardiovascular preventive care and a lower risk of cardiovascular events among cancer survivors.

The study will use nationwide health insurance and cancer registry data from Korea. Adults with a history of cancer who are alive at least 1 year after cancer diagnosis, have no prior major cardiovascular disease, and are not receiving statin therapy at the start of an eligible study period will be included.

The investigators will compare cancer survivors who undergo LDL-C testing with similar cancer survivors who do not undergo LDL-C testing. Participants will not be assigned to receive testing or treatment by the investigators. Instead, routinely collected health care data will be analyzed.

The main outcome will be major adverse cardiovascular and cerebrovascular events, including cardiovascular death, myocardial infarction, stroke, and coronary revascularization. The study will also examine whether LDL-C testing is associated with subsequent initiation of statin therapy.

The findings may help determine whether routine lipid testing can support cardiovascular disease prevention as part of long-term survivorship care for people with cancer.

Status and Timeline

Status: Completed
Last Update Posted: Jul 31, 2026Actual
Start Date: Jan 1, 2016Actual
Primary Completion Date: Dec 31, 2023Actual
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: Inclusion Criteria:

Individuals with a diagnosis of cancer recorded in the nationwide cancer registry and health insurance database

Alive and under observation at least 1 year after the initial cancer diagnosis

Eligible for entry at an annual emulated trial baseline

Not receiving statin therapy at the corresponding trial baseline

Available information on age, sex, cancer type, year of cancer diagnosis, cancer stage, diabetes mellitus, hypertension, and dyslipidemia

Continuous eligibility for outcome ascertainment in the national health insurance database

Exclusion Criteria:

History of cardiovascular disease before the corresponding trial baseline

History of myocardial infarction or stroke before the corresponding trial baseline

History of familial hypercholesterolemia

History of percutaneous coronary intervention or coronary artery bypass grafting

Use of statin therapy before or at the corresponding trial baseline

Missing information required to determine eligibility, exposure status, or prespecified baseline covariates

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 1,294,726Actual
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking

Contacts and Locations

Central Contacts: No data available
Locations: No data available

Similar Studies

Participant Group/Arms

Annual LDL-C Testing

Statin-naive cancer survivors who met the eligibility criteria at an annual emulated trial baseline and underwent low-density lipoprotein cholesterol (LDL-C) testing during the prespecified assessment period. LDL-C testing was identified from routinely collected health insurance claims. Testing was not assigned by the investigators. Participants were followed for statin initiation and major adverse cardiovascular and cerebrovascular events.

No Annual LDL-C Testing

Statin-naive cancer survivors who met the eligibility criteria at an annual emulated trial baseline and did not undergo low-density lipoprotein cholesterol (LDL-C) testing during the corresponding assessment period. Testing was not assigned by the investigators. Participants were followed for statin initiation and major adverse cardiovascular and cerebrovascular events. For cardiovascular outcome analyses, follow-up was censored if LDL-C testing subsequently occurred.