Johns Hopkins Breast Cancer Program Longitudinal Repository

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Sidney Kimmel Comprehensive Cancer Center
Sponsor:
Information provided by (Responsible Party):
Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT01937039
First received: September 3, 2013
Last updated: October 1, 2014
Last verified: October 2014
  Purpose

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 Intervention
Breast Cancer
Benign Breast Disease
Procedure: Sample collection

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Johns Hopkins Breast Cancer Program Longitudinal Repository

Resource links provided by NLM:


Further study details as provided by Sidney Kimmel Comprehensive Cancer Center:

Primary Outcome Measures:
  • Repository development [ Time Frame: 20 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 1000
Study Start Date: April 2009
Estimated Study Completion Date: January 2030
Estimated Primary Completion Date: January 2030 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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:

  • N/A
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Sidney Kimmel Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT01937039     History of Changes
Other Study ID Numbers: J0888, SKCCC J0888
Study First Received: September 3, 2013
Last Updated: October 1, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 20, 2014