Routine LDL Exam For Cancer Survivors

NCT07738250 | Completed

• 1 other identifier: Routine LDL Exam After Cancer
• Study Type: observational
• Target: 1,294,726
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cancer Survivorship; Cardiovascular Disease

Keywords

cancer survivors; survivorship care; cardio-oncology; lipid surveillance; statin initiation; MACCE; target trial emulation

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular and Cerebrovascular Events

  First occurrence of a composite outcome comprising cardiovascular death, myocardial infarction, stroke, or coronary revascularization. Cardiovascular outcomes will be identified using prespecified diagnosis, procedure, and mortality records from nationwide health insurance and linked registry data. Only the first event occurring after each annual emulated trial baseline will be counted for the primary analysis.

  From each annual emulated trial baseline through up to 6 years of follow-up

Secondary Outcomes (1)

• Initiation of Statin Therapy

  Within 1 year after each annual emulated trial baseline

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population consists of cancer survivors identified from a nationwide Korean cancer registry linked to national health insurance claims. Eligibility is reassessed at a series of annual emulated trial baselines beginning 1 year after cancer diagnosis. Individuals may contribute to more than one annual trial if they continue to meet all eligibility criteria. At each baseline, participants must be alive, statin-naive, and free of prior cardiovascular disease, myocardial infarction, stroke, familial hypercholesterolemia, percutaneous coronary intervention, and coronary artery bypass grafting. Participants are classified according to whether annual LDL-C testing occurred, and are followed for statin initiation and cardiovascular outcomes.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• Institution of cancer quality of life, Samsung Medical Center: collaborator

MeSH Terms

Conditions

Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 26, 2026
• First Posted: July 31, 2026
• Study Start: January 1, 2016
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: July 31, 2026

Record last verified: 2026-05