Breast CancerNCT01937039
Johns Hopkins Breast Cancer Program Longitudinal Repository
An observational study of Breast Cancer and Benign Breast Disease, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Benign Breast Disease
- What is being tested?
- Sample collection
- Type of treatment
- Surgery or procedure
- How many people
- 810 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2009to Jan 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- N/A
Trial locations and contacts
1 site in 1 country.
United States1 site
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287-0013
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Benign Breast Disease
- Being tested
- Sample collection
- Medical subject headings
- Breast Neoplasms, Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sample collectionProcedure or surgery
Blood, tissue, urine, and other samples may be collected
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Procedure: Sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 20 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study startApr 2009
- Primary completionJan 2030 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 810 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Responsible party
- Sponsor
- Investigators
- Antonio C. Wolff, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937039
- Sponsor's protocol ID
- J0888
- Other IDs
- SKCCC J0888, NA_00019811
- Status last verified
- May 2026
- First submitted
- 3 Sep 2013
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Johns Hopkins Breast Cancer Program Longitudinal Repository
- ClinicalTrials.gov ID
- NCT01937039
- Acronym / sponsor ID
- J0888
- Conditions
- Breast Cancer, Benign Breast Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 810 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- Susan G. Komen Breast Cancer Foundation
- Study start
- Apr 2009
- Primary completion
- Jan 2030 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 9 Sep 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patients | – | Procedure: Sample collectionParticipants 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. |
| Benign breast disease | – | Procedure: Sample collectionParticipants 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. |
| Healthy volunteer | – | Procedure: Sample collectionParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sample collectionBlood, tissue, urine, and other samples may be collected | Procedure or surgery | Benign breast disease, Breast cancer patients, Healthy volunteer |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio C. Wolff, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Benign Breast Disease, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Repository development (time frame: 20 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.