NCT01937039

Brief Summary

The Breast Cancer Program Longitudinal Repository (BCPLR) is being established to fulfill the research mission of the Breast Cancer Program at Johns Hopkins and to serve investigators affiliated with it - to develop a repository of specimens with corresponding characteristics from patients seen in the breast care and cancer clinics.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
810

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Apr 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Apr 2009Jan 2030

Study Start

First participant enrolled

April 1, 2009

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 9, 2013

Completed
16.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2030

Last Updated

May 1, 2025

Status Verified

April 1, 2025

Enrollment Period

20.8 years

First QC Date

September 3, 2013

Last Update Submit

April 28, 2025

Conditions

Breast CancerBenign Breast Disease

Outcome Measures

Primary Outcomes (1)

  • Repository development

    To develop a repository of specimens with corresponding characteristics - demographic and clinical information - from patients seen in the breast care and cancer clinics

    20 years

Study Arms (3)

Breast cancer patients

Participants have a known diagnosis of breast cancer and are receiving a breast cancer evaluation and/or treatment, who agree to sample collection, access, and follow-up as part of the repository.

Procedure: Sample collection

Benign breast disease

Participants have benign breast disease and are receiving a diagnostic procedure and/or evaluation, who agree to sample collection, access, and follow-up as part of the repository.

Procedure: Sample collection

Healthy volunteer

Participants have no known diagnosis of breast disease or abnormality and are undergoing routine screening or diagnostic breast imaging procedures and/or other clinical evaluation, who agree to sample collection, access, and follow-up as part of the repository.

Procedure: Sample collection

Interventions

Sample collectionPROCEDURE

Blood, tissue, urine, and other samples may be collected

Benign breast diseaseBreast cancer patientsHealthy volunteer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any man or woman being seen at Johns Hopkins for breast cancer treatment, or for any screening or diagnostic breast procedures (for example: mammograms or biopsies), may join. Individuals without a history of breast cancer, known as "healthy" or "normal" volunteers (meaning they do not have breast cancer) may also join.

You may qualify if:

  • Male or female
  • years of age or older
  • Participants meet one of the following categories: have a known diagnosis of breast cancer receiving a breast cancer evaluation and/or treatment; have benign breast disease receiving a diagnostic procedure and/or evaluation; or, have no known diagnosis of breast disease or abnormality and is undergoing routine screening or diagnostic breast imaging procedures and/or other clinical evaluation.

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21287-0013, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood for example: whole blood, serum, plasma, urine, and tissue samples.

MeSH Terms

Conditions

Breast NeoplasmsCystic Fibrosis

Interventions

Specimen Handling

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Study Officials

  • Antonio C. Wolff, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2013

First Posted

September 9, 2013

Study Start

April 1, 2009

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

January 1, 2030

Last Updated

May 1, 2025

Record last verified: 2025-04

Locations

US(1)