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Johns Hopkins Breast Cancer Program Longitudinal Repository

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ClinicalTrials.gov Identifier: NCT01937039
Recruitment Status : Recruiting
First Posted : September 9, 2013
Last Update Posted : October 18, 2017
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment
Breast Cancer Benign Breast Disease Procedure: Sample collection

Detailed Description:
This research is being done to collect samples for future use that we may learn more about cancer by studying cells in blood and tissue collected from people with breast cancer as well as from volunteers without breast cancer. Our goal is to make these available for research to help to learn how cancer develops and how it may be treated.

Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Johns Hopkins Breast Cancer Program Longitudinal Repository
Study Start Date : April 2009
Estimated Primary Completion Date : January 2030
Estimated Study Completion Date : January 2030

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
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
Blood, tissue, urine, and other samples may be collected
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
Blood, tissue, urine, and other samples may be collected
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
Blood, tissue, urine, and other samples may be collected



Primary Outcome Measures :
  1. Repository development [ Time Frame: 20 years ]
    To develop a repository of specimens with corresponding characteristics - demographic and clinical information - from patients seen in the breast care and cancer clinics


Biospecimen Retention:   Samples With DNA
Blood for example: whole blood, serum, plasma, urine, and tissue samples


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-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.
Criteria

Inclusion Criteria:

  • Male or female
  • 18 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.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01937039


Locations
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Recruiting
Baltimore, Maryland, United States, 21287-0013
Contact: Hopkins Breast Trials       HopkinsBreastTrials@jhmi.edu   
Sponsors and Collaborators
Sidney Kimmel Comprehensive Cancer Center
Investigators
Study Chair: Antonio C. Wolff, MD Sidney Kimmel Comprehensive Cancer Center

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01937039     History of Changes
Other Study ID Numbers: J0888
SKCCC J0888 ( Other Identifier: SKCCC at Johns Hopkins )
First Posted: September 9, 2013    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Fibrocystic Breast Disease
Neoplasms by Site
Neoplasms
Skin Diseases