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Cardiometabolic Screening for Breast Cancer Survivors

N/A
Recruiting
Led By Jennifer Sheng, M.D.
Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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.
Diagnosis of early stage breast cancer
Must not have
Metastatic breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a screening program to catch early signs of diabetes, high cholesterol, and other heart disease risk factors in breast cancer survivors. The goal is to get patients help and treatment before these conditions worsen.

Who is the study for?
This clinical trial is for early-stage breast cancer survivors who have finished their local or systemic therapy at least 3 months ago. Participants must be receiving care through specific Johns Hopkins Medical Institute locations and be able to read and speak English. Those with metastatic breast cancer cannot join.
What is being tested?
The study aims to implement a screening program for conditions like prediabetes, diabetes, dyslipidemia, hyperlipidemia, and increased cardiovascular disease risk in breast cancer survivors. It includes various assessments such as HbA1c levels, lipid panels, BMI evaluations, and cardiovascular risk predictions.
What are the potential side effects?
Since this trial focuses on screening rather than medication or invasive procedures, there are no direct side effects from the interventions being studied. However, participants may experience stress or anxiety related to learning about their potential health risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am receiving breast cancer treatment at Johns Hopkins or its associated clinics.
Select...
I have been diagnosed with early stage breast cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My breast cancer has spread to other parts of my body.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Breast
Change in HbA1c
Change in LDL cholesterol
+5 more
Secondary study objectives
Cardiovascular risk factors (family history)
Cardiovascular risk factors (hypertension)
Cardiovascular risk factors (tobacco use)
+6 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Early stage breast cancer survivorsExperimental Treatment9 Interventions
Patients with history of early stage breast cancer and at least 3 months from completion of local and systemic therapy at Johns Hopkins
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Follow-Up
2019
N/A
~50
Baseline
2007
Completed Phase 2
~360
Recommendations
2011
N/A
~30

Find a Location

Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor
570 Previous Clinical Trials
32,780 Total Patients Enrolled
44 Trials studying Breast Cancer
4,522 Patients Enrolled for Breast Cancer
Jennifer Sheng, M.D.Principal InvestigatorSidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Media Library

Screening and Enrollment Clinical Trial Eligibility Overview. Trial Name: NCT05386719 — N/A
Breast Cancer Research Study Groups: Early stage breast cancer survivors
Breast Cancer Clinical Trial 2023: Screening and Enrollment Highlights & Side Effects. Trial Name: NCT05386719 — N/A
Screening and Enrollment 2023 Treatment Timeline for Medical Study. Trial Name: NCT05386719 — N/A
~77 spots leftby Jun 2025
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