NCT06773897

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25,000

participants targeted

Target at P75+ for all trials

Timeline
12mo left

Started Apr 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress68%
Apr 2024Apr 2027

Study Start

First participant enrolled

April 15, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 14, 2025

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2026

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2027

Expected
Last Updated

October 27, 2025

Status Verified

October 1, 2025

Enrollment Period

2 years

First QC Date

January 8, 2025

Last Update Submit

October 23, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    2 years

Study Arms (2)

Breast Cancer Cases

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

Genetic: Saliva sampleOther: Health Surveys

Breast Cancer Controls

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

Genetic: Saliva sampleOther: Health Surveys

Interventions

Saliva sample is sent via prepaid US Mail for DNA extraction

Breast Cancer CasesBreast Cancer Controls

Health surveys are filled out online in the study portal.

Breast Cancer CasesBreast Cancer Controls

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rutgers University

Piscataway, New Jersey, 08854, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Health Surveys

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Surveys and QuestionnairesData CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Officials

  • Tara Matise, Ph.D.

    Rutgers, The State University of New Jersey

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Tara Matise, Ph.D.

CONTACT

Steve Buyske, Ph.D.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Distinguished Professor

Study Record Dates

First Submitted

January 8, 2025

First Posted

January 14, 2025

Study Start

April 15, 2024

Primary Completion

April 15, 2026

Study Completion (Estimated)

April 30, 2027

Last Updated

October 27, 2025

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations