Rutgers University Study of the Genetics of Breast Cancer.

NCT06773897 — Recruiting, 25000 participants, Rutgers, The State University of New Jersey

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The Rutgers University Genetics Coordinating Center Breast Cancer Study

Registry	NCT06773897, acronym RUGCC-BC
Status	Recruiting
Study type	Observational
Enrollment	25000 (Estimated)
Sponsor	Rutgers, The State University of New Jersey (Other); collaborators: Regeneron Pharmaceuticals
Conditions	Breast Cancer Risk, Breast Cancer Prevention, Breast Cancer
Interventions	Saliva sample, Health Surveys (Genetic, other)
Dates	start 2024-04-15, primary completion 2028-04-15 (estimated), completion 2028-04-30 (estimated), first posted 2025-01-14, last updated 2026-10-16
Locations	1 site in United States

-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. 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.

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Breast Cancer Cases		Genetic: Saliva sample; Other: Health Surveys	Study 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 Surveys	Study participants who have never had a diagnosis of breast cancer.

Saliva sample (Genetic): Saliva sample is sent via prepaid US Mail for DNA extraction
Health Surveys (Other): Health surveys are filled out online in the study portal.

+Outcome measures

Primary outcomes

Genetic risk variants associated with breast cancer [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.

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Not able to meet or fulfill any of the inclusion criteria

+Locations (1)

Facility	City	Country	Status
Rutgers University	Piscataway, New Jersey	United States	Recruiting

+Investigators

Tara Matise, Ph.D., Principal investigator, Rutgers, The State University of New Jersey