Rutgers University Study of the Genetics of Breast Cancer.

Recruiting

• Conditions: Breast Cancer Risk; Breast Cancer Prevention; Breast Cancer

• Registration Number: NCT06773897
• Lead Sponsor: Rutgers, The State University of New Jersey

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.

Study Timeline

• Study Start: 2024-04-15
• Status Verified: 2025-01
• Study First Submitted: 2025-01-08
• Study First Submitted QC: 2025-01-08
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-15
• Primary Completion: 2026-04-15
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 10000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Rutgers University; 🇺🇸 Piscataway, New Jersey, United States