Clinical trial · Interventional
Cardiometabolic Screening Program
A Cardiometabolic Screening Program for Breast Cancer Survivors
NCT05386719CI-TRIAL-00125543recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Early-stage Breast Cancer | Early Stage Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (9)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Assess 10 year risk of cardiovascular event | Behavioral | — | UNRESOLVED |
| Baseline | Behavioral | — | UNRESOLVED |
| Follow-Up | Behavioral | — | UNRESOLVED |
| Interpret BMI | Behavioral | — | UNRESOLVED |
| Interpret HbA1c | Other | — | UNRESOLVED |
| Interpret lipid panel and assess other risk factors | Other | — | UNRESOLVED |
| Prescreening | Other | — | UNRESOLVED |
| Recommendations | Behavioral | — | UNRESOLVED |
| Screening and Enrollment |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Early stage breast cancer survivors
- description
- Patients with history of early stage breast cancer and at least 3 months from completion of local and systemic therapy at Johns Hopkins
- interventionNames
- Other: Prescreening
- Other: Screening and Enrollment
- Behavioral: Baseline
- Behavioral: Interpret BMI
- Other: Interpret HbA1c
- Other: Interpret lipid panel and assess other risk factors
- Behavioral: Assess 10 year risk of cardiovascular event
- Behavioral: Recommendations
- Behavioral: Follow-Up
Primary outcomes (8)
- measure
- Prevalence of prediabetes
- timeFrame
- 3 years
- description
- The proportion of women with early stage breast cancer who have prediabetes: The number is determined through medical history, laboratory results, and baseline survey. Prevalence of prediabetes, will be estimated with an exact 95% confidence interval.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.