Breast CancerPINKNCT00945464
Scripps Polster Breast Care Center Investigational GeneBank
An observational study of Breast Cancer, run by Scripps Translational Science Institute at 1 site in United States.
Trial summary
Breast cancer is a disease of complex origin with a strong genetic component. The incidence of breast cancer is very high in monozygotic twins of patients, and it is thought that a high proportion and perhaps the majority of breast cancers arise in a small number of genetically susceptible women. Read more about this study
- Who is it for?
- Ages 30 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Blood/saliva samples, historic breast imaging
- How many people
- 1,136 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Jun 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women over the age of 30 undergoing breast imaging at the Scripps Polster Breast Care Center.
Who may be able to join
- Age 30 years or older
- Be reliable, cooperative and willing to comply with all protocol-specified procedures
- Able to understand and grant informed consent
- Be undergoing screening or diagnostic breast imaging
- Have at least 5 years of breast imaging data available
Who cannot join
- Have a significant chronic medical condition which, in the Investigator's opinion, would interfere with the subject's participation in the study
- Have undergone treatment with any investigational agents or devices within thirty days preceding enrollment in the study
- Have taken any CNS sedation or depressants in past 12 hours
Trial locations and contacts
1 site in 1 country.
United States1 site
Scripps Polster Breast Care Center
La Jolla, California, 92037
About this study
Breast cancer is a disease of complex origin with a strong genetic component. The incidence of breast cancer is very high in monozygotic twins of patients, and it is thought that a high proportion and perhaps the majority of breast cancers arise in a small number of genetically susceptible women. Recent studies in human genetics have discovered several intervals in the human genome containing inherited variants that are statistically associated with the propensity to develop breast cancer. The investigators plan to use this knowledge to design a genetic screening test to guide recommendations for breast cancer screening with mammography. If the small group of genetically susceptible women can be identified, more effective breast cancer screening strategies can be implemented. In contrast, a very large proportion of women who undergo yearly mammography are at exceptionally low risk from a genetic perspective. Using genomic guidance could eventually reconfigure the most efficacious strategy to screen women for early detection of breast cancer.
By developing a genetic screening panel based on genetic markers for breast cancer, the investigators will be able to more accurately determine a woman's individual risk for developing breast cancer.
Read the detailed description
Women the age of 30 or over who are undergoing screening or diagnostic breast imaging as an out patient at the Scripps Polster Breast Care Center in La Jolla, CA, with at least 5 years of historic breast imaging data available will be eligible to enroll. For this study, consecutive subjects who have completed screening or diagnostic breast imaging at the Scripps Polster Breast Care Center will be enrolled for one day. It is estimated that up to 5000 subjects will be included in the cohort.
- Conditions
- Breast Cancer
- Being tested
- Blood/saliva samples, historic breast imaging
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood/saliva samples, historic breast imagingOther
Subjects are required only to provide a blood or saliva sample, relevant personal and family history (if available), and 5 years of historic breast imaging reports.
| Study group | Role | What they receive |
|---|---|---|
| No treatment | Women over the age of 30 undergoing breast imaging at the Scripps Polster Breast Care Center. Receives: Other: Blood/saliva samples, historic breast imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genotyping
Genotype a panel of single nucleotide polymorphisms (SNPs) previously shown to be highly associated with increased risk to breast cancer in a cohort of women with either at least 5 years of historical breast imaging data available or 30-45 year old breast cancer patients with at least one year imaging data
Measured: End of study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2009 (estimated)
- Study startJul 2008
- Primary completionJun 2015
- Study completionJun 2015
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.
- 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
- Cohort
- Enrolment
- 1,136 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scripps Translational Science Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eric Topol, MD, Scripps Translational Science Institute
- Investigators
- Eric J Topol, MD, Principal investigator, Scripps Translational Science Institute and Genomic Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00945464
- Sponsor's protocol ID
- LAJ 08-8001
- Acronym
- PINK
- Status last verified
- Oct 2015
- First submitted
- 22 Jul 2009
- Last updated
- 16 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scripps Polster Breast Care Center Investigational GeneBank
- ClinicalTrials.gov ID
- NCT00945464
- Acronym / sponsor ID
- PINK / LAJ 08-8001
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,136 participants (actual)
- Lead sponsor
- Scripps Translational Science InstituteUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 24 Jul 2009 (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.
Breast cancer is a disease of complex origin with a strong genetic component. The incidence of breast cancer is very high in monozygotic twins of patients, and it is thought that a high proportion and perhaps the majority of breast cancers arise in a small number of genetically susceptible women. Recent studies in human genetics have discovered several intervals in the human genome containing inherited variants that are statistically associated with the propensity to develop breast cancer. The investigators plan to use this knowledge to design a genetic screening test to guide recommendations for breast cancer screening with mammography. If the small group of genetically susceptible women can be identified, more effective breast cancer screening strategies can be implemented. In contrast, a very large proportion of women who undergo yearly mammography are at exceptionally low risk from a genetic perspective. Using genomic guidance could eventually reconfigure the most efficacious strategy to screen women for early detection of breast cancer.
By developing a genetic screening panel based on genetic markers for breast cancer, the investigators will be able to more accurately determine a woman's individual risk for developing breast cancer.
Detailed description
Women the age of 30 or over who are undergoing screening or diagnostic breast imaging as an out patient at the Scripps Polster Breast Care Center in La Jolla, CA, with at least 5 years of historic breast imaging data available will be eligible to enroll. For this study, consecutive subjects who have completed screening or diagnostic breast imaging at the Scripps Polster Breast Care Center will be enrolled for one day. It is estimated that up to 5000 subjects will be included in the cohort.
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| No treatment | – | Other: Blood/saliva samples, historic breast imagingWomen over the age of 30 undergoing breast imaging at the Scripps Polster Breast Care Center. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women over the age of 30 undergoing breast imaging at the Scripps Polster Breast Care Center.
Key inclusion criteria (5 listed)
- Age 30 years or older
- Be reliable, cooperative and willing to comply with all protocol-specified procedures
- Able to understand and grant informed consent
- Be undergoing screening or diagnostic breast imaging
- Have at least 5 years of breast imaging data available
Key exclusion criteria (3 listed)
- Have a significant chronic medical condition which, in the Investigator's opinion, would interfere with the subject's participation in the study
- Have undergone treatment with any investigational agents or devices within thirty days preceding enrollment in the study
- Have taken any CNS sedation or depressants in past 12 hours
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 |
|---|---|---|
| Blood/saliva samples, historic breast imagingSubjects are required only to provide a blood or saliva sample, relevant personal and family history (if available), and 5 years of historic breast imaging reports. | Other | No treatment |
Primary outcome
Genotyping
Time frame: End of study
Genotype a panel of single nucleotide polymorphisms (SNPs) previously shown to be highly associated with increased risk to breast cancer in a cohort of women with either at least 5 years of historical breast imaging data available or 30-45 year old breast cancer patients with at least one year imaging data
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2015.
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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.
Eric J Topol, MD principal investigator
Scripps Translational Science Institute and Genomic Medicine
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, run by Scripps Translational Science Institute 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 16 Oct 2015. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Genotyping (time frame: End of study). 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 16 Oct 2015.