Breast Cancer RiskRUGCC-BCNCT06773897
Rutgers University Study of the Genetics of Breast Cancer.
An observational study of Breast Cancer Risk and Breast Cancer Prevention, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The goal of this observational study is to learn more about how genes impact the risk of breast cancer. Anyone 18 or older living in the US is eligible, and a diagnosis of cancer is NOT required. 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 Risk, Breast Cancer Prevention, Breast Cancer
- What is being tested?
- Saliva sample and Health Surveys
- How many people
- 25,000 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2024to 30 Apr 2028
- 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: The study population consists of anyone at least 18 years old who lives in the United States, including both individuals who have or had breast cancer and those who have not. Participants include males, females, non-binary, and all race-ethnic groups.
Who may be able to join
- age 18 years or older
- currently living in the United States
- able to understand and follow written instructions in English
- have access to the internet and a computer, laptop, tablet or smart phone
- willing to provide written informed consent for participation
- willing to provide DNA via a saliva sample using a collection kit mailed to the study participant's home
- willing to complete a survey with questions about health related to the study of breast cancer.
Who cannot join
- Not able to meet or fulfill any of the inclusion criteria
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Rutgers University
Piscataway, New Jersey, 08854
Tara Matise, Ph.D., 848-445-3125, rugcc@rutgers.edu
About this study
Official title: The Rutgers University Genetics Coordinating Center Breast Cancer Study
The goal of this observational study is to learn more about how genes impact the risk of breast cancer. Anyone 18 or older living in the US is eligible, and a diagnosis of cancer is NOT required. Study participation is online, and it takes about 20 minutes to complete health surveys and request a saliva collection kit sent through US mail. In return, study participants may opt to receive information about their genetic ancestry at no cost.
Read the detailed description
This is an online research study to learn more about how genes affect the risk of breast cancer. No office visit is required and in return, participants may receive information about their genetic ancestry for free. BRCA1 and BRCA2 explain only about 25% of the genetic cause of breast cancer. This study will increase our understanding of the genetic basis of breast cancer, which is a crucial step in drug development to improve current treatment options. The study investigators seek a diverse population because men can also get breast cancer and diversity among participants maximizes the usefulness of the data. Participants will use our online study portal to answer questions about their health and provide their DNA via a saliva sample using a pre-paid mailer. Participation takes approximately 20 minutes. Participants will be invited to share data from their electronic health records, but this is not required for study participation. The study investigators keep participants engaged with short monthly newsletters.
- Conditions
- Breast Cancer Risk, Breast Cancer Prevention, Breast Cancer
- Being tested
- Saliva sample, Health Surveys
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saliva sampleGenetic
Saliva sample is sent via prepaid US Mail for DNA extraction
Health SurveysOther
Health surveys are filled out online in the study portal.
| Study group | Role | What they receive |
|---|---|---|
| Breast Cancer Cases | Study participants who have been diagnosed with any form of breast cancer, either currently or in the past. Receives: Genetic: Saliva sample; Other: Health Surveys | |
| Breast Cancer Controls | Study participants who have never had a diagnosis of breast cancer. Receives: Genetic: Saliva sample; Other: Health Surveys |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic risk variants associated with breast cancer
Genetic factors will be measured through whole exome sequencing along with genotyping of common variants, and then correlated with breast cancer and breast cancer subtype.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start15 Apr 2024
- Primary completion15 Apr 2028 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer RiskStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 25,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Responsible party
- Principal investigator, Tara Matise, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Tara Matise, Ph.D., Principal investigator, Rutgers, The State University of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773897
- Sponsor's protocol ID
- Pro2023001275
- Acronym
- RUGCC-BC
- Status last verified
- Oct 2026
- First submitted
- 8 Jan 2025
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Rutgers University Genetics Coordinating Center Breast Cancer Study
- ClinicalTrials.gov ID
- NCT06773897
- Acronym / sponsor ID
- RUGCC-BC / Pro2023001275
- Conditions
- Breast Cancer Risk, Breast Cancer Prevention, Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 25,000 participants (estimated)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Regeneron Pharmaceuticals
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 15 Apr 2028 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 14 Jan 2025 (actual)
- 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 goal of this observational study is to learn more about how genes impact the risk of breast cancer. Anyone 18 or older living in the US is eligible, and a diagnosis of cancer is NOT required. Study participation is online, and it takes about 20 minutes to complete health surveys and request a saliva collection kit sent through US mail. In return, study participants may opt to receive information about their genetic ancestry at no cost.
Detailed description
This is an online research study to learn more about how genes affect the risk of breast cancer. No office visit is required and in return, participants may receive information about their genetic ancestry for free. BRCA1 and BRCA2 explain only about 25% of the genetic cause of breast cancer. This study will increase our understanding of the genetic basis of breast cancer, which is a crucial step in drug development to improve current treatment options. The study investigators seek a diverse population because men can also get breast cancer and diversity among participants maximizes the usefulness of the data. Participants will use our online study portal to answer questions about their health and provide their DNA via a saliva sample using a pre-paid mailer. Participation takes approximately 20 minutes. Participants will be invited to share data from their electronic health records, but this is not required for study participation. The study investigators keep participants engaged with short monthly newsletters.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Cases | – | Genetic: Saliva sample, Other: Health SurveysStudy participants who have been diagnosed with any form of breast cancer, either currently or in the past. |
| Breast Cancer Controls | – | Genetic: Saliva sample, Other: Health SurveysStudy participants who have never had a diagnosis of breast cancer. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of anyone at least 18 years old who lives in the United States, including both individuals who have or had breast cancer and those who have not. Participants include males, females, non-binary, and all race-ethnic groups.
Key inclusion criteria (7 listed)
- age 18 years or older
- currently living in the United States
- able to understand and follow written instructions in English
- have access to the internet and a computer, laptop, tablet or smart phone
- willing to provide written informed consent for participation
Key exclusion criteria (1 listed)
- Not able to meet or fulfill any of the inclusion criteria
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 |
|---|---|---|
| Saliva sampleSaliva sample is sent via prepaid US Mail for DNA extraction | Genetic | Breast Cancer Cases, Breast Cancer Controls |
| Health SurveysHealth surveys are filled out online in the study portal. | Other | Breast Cancer Cases, Breast Cancer Controls |
Primary outcome
Genetic risk variants associated with breast cancer
Time frame: 2 years
Genetic factors will be measured through whole exome sequencing along with genotyping of common variants, and then correlated with breast cancer and breast cancer subtype.
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 16 Oct 2026.
- Study portal for participant enrollment and study engagement.Link provided by the sponsor.
- Study website with detailed information about the study.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Tara Matise, Ph.D. principal investigator
Rutgers, The State University of New Jersey
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 Risk and Breast Cancer Prevention, run by Rutgers, The State University of New Jersey 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 7 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: looking for participants now, as of the sponsor's last update on 16 Oct 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?
Contact Tara Matise, Ph.D. (848-445-3125, rugcc@rutgers.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genetic risk variants associated with breast cancer (time frame: 2 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 16 Oct 2026.