Recruiting

Cardiometabolic Screening

Sponsor:

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Code:

NCT05386719

Conditions

Breast Cancer

Early-stage Breast Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Prescreening

Screening and Enrollment

Baseline

Interpret BMI

Interpret HbA1c

Study Details

Brief summary:

This research study is being done to implement a screening program for prediabetes, diabetes, dyslipidemia and/or hyperlipidemia, and higher risk of cardiovascular disease in breast cancer survivors. This program will also help to direct individuals with risk factors to community and institutional resources for management.

Conditions

Breast Cancer

Early-stage Breast Cancer

Study ID

NCT05386719

Start date

Jun 3, 2022

Status verified date

Sep, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Diagnosis of early stage breast cancer
  • Completed local and/or systemic therapy at least 3 months ago
  • Receiving medical oncology care at through the breast cancer clinics at Johns Hopkins Medical Institute, including the Sidney Kimmel Comprehensive Cancer Center in Baltimore MD and Green Spring Station in Lutherville-Timonium MD, and Sibley Memorial Hospital in Washington D.C.
  • Read and speak English

Exclusion Criteria:

  • Metastatic breast cancer

Study Design

Enrollment

450 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: Early stage breast cancer survivors

Patients with history of early stage breast cancer and at least 3 months from completion of local and systemic therapy at Johns Hopkins

Interventions

Prescreening

Eligible patients (history of early stage breast cancer and at least 3 months from completion of local and systemic therapy at Johns Hopkins, reads and speaks English) complete survey for demographics, smoking status \& questions about cardiovascular disease.

Screening and Enrollment

Consent

Baseline

Behavioral Battery and Patient Reported Outcome Quality of Life questionnaires (EORTC QLQ-C30 and QLQ-BR23) Labs (Hba1c + lipid panel if not done within 12 months or if abnormal within 1 year) Abstract vitals from chart review

Interpret BMI

Refer to Healthful Eating, Activity and Weight Program (HEAWP) if BMI ≥25 and not already on lifestyle intervention

Interpret HbA1c

HbA1c results categorized as follows:

HbA1c <5.7%; HbA1c 5.7-6.4%; HbA1c 6.5%+; or Known diabetic on medication

Interpret lipid panel and assess other risk factors

Based on above categories:

HbA1c <5.7%: Any of these cardiovascular disease risk factors: current/former tobacco use, total cholesterol >200, family history of Coronary Artery Disease/Heart Attack in first degree family <55 year old male or <65 year old female, systolic blood pressure >130 HbA1c 5.7-6.4%: Refer to Primary Care Provider and consider Healthful Eating, Activity and Weight Program (HEAWP) HbA1c 6.5%+: Refer to Endocrinology if HbA1c ≥8% Known diabetic on medication: Refer to Endocrinology if HbA1c ≥7%

Assess 10 year risk of cardiovascular event

If risk factors are present - refer to Cardiovascular Disease Prevention Program

Recommendations

Provide individual patient handout based on all above interventions

Follow-Up

6 and 12 month labs (if prior abnormal) and Patient Reported Outcome questionnaires

Primary outcome measure

  • Prevalence of prediabetes [ Time Frame: 3 years ]
  • Prevalence of diabetes [ Time Frame: 3 years ]
  • Prevalence of hyperlipidemia [ Time Frame: 3 years ]
  • Change in HbA1c [ Time Frame: Baseline, 6 months, 12 months ]
  • Change in LDL cholesterol [ Time Frame: Baseline, 6 months, 12 months ]
  • Prevalence of obesity/ overweight [ Time Frame: Baseline, 6 months, 12 months ]
  • Quality of Life Questionnaire The European Organisation for Research and Treatment Cancer C30 [ Time Frame: Baseline, 6 months, 12 months ]
  • Breast-specific symptoms assessed by the of The European Organisation for Research and Treatment Cancer Quality of Life Questionnaire BR-23 [ Time Frame: Baseline, 6 months, 12 months ]

Central Contacts and Locations

Central contacts

Hopkins Breast Trials

410-614-1361HopkinsBreastTrials@jhmi.edu

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

410-955-8804jhcccro@jhmi.edu

Locations

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Recruiting

Baltimore, Maryland, United States, 21231-1000

Contacts

Vered Stearns, MD

443-287-6547

More Information

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • Survivor

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins on 2026-09-03.