Rutgers University Study of the Genetics of Breast Cancer.

NCT ID: NCT06773897

Last Updated: 2025-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

25000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-15

Study Completion Date

2027-04-30

Brief Summary

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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

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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

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Breast Cancer Risk Breast Cancer Prevention Breast Cancer

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Breast Cancer Cases

Study participants who have been diagnosed with any form of breast cancer, either currently or in the past.

Saliva sample

Intervention Type GENETIC

Saliva sample is sent via prepaid US Mail for DNA extraction

Health Surveys

Intervention Type OTHER

Health surveys are filled out online in the study portal.

Breast Cancer Controls

Study participants who have never had a diagnosis of breast cancer.

Saliva sample

Intervention Type GENETIC

Saliva sample is sent via prepaid US Mail for DNA extraction

Health Surveys

Intervention Type OTHER

Health surveys are filled out online in the study portal.

Interventions

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Saliva sample

Saliva sample is sent via prepaid US Mail for DNA extraction

Intervention Type GENETIC

Health Surveys

Health surveys are filled out online in the study portal.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role collaborator

Rutgers, The State University of New Jersey

OTHER

Sponsor Role lead

Responsible Party

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Tara Matise, Ph.D.

Distinguished Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Tara Matise, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Rutgers, The State University of New Jersey

Locations

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Rutgers University

Piscataway, New Jersey, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Tara Matise, Ph.D.

Role: CONTACT

848-445-3125

Steve Buyske, Ph.D.

Role: CONTACT

848-445-7680

Facility Contacts

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Tara Matise, Ph.D.

Role: primary

848-445-3125

Related Links

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https://rugcc.rutgers.edu/breast_cancer/

Study website with detailed information about the study.

https://go.rutgers.edu/BCStudyCTG

Study portal for participant enrollment and study engagement.

Other Identifiers

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Pro2023001275

Identifier Type: -

Identifier Source: org_study_id

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