Clinical trial NCT06773897: Rutgers University Study of the Genetics of Breast Cancer.
Official title: The Rutgers University Genetics Coordinating Center Breast Cancer Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer Risk
Breast Cancer Prevention
Breast Cancer
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
Collaborators: name: Regeneron Pharmaceuticals
First posted: 2025-01-14
Enrollment: 10000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Genetic risk variants associated with breast cancer
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers University
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Tara Matise, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: