NCT04002986

Brief Summary

Researchers are trying to learn more about the prevalence of genetic mutations in women who are at intermediate/high risk of breast cancer and how that information my assist providers in improving screening and preventative options.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2019

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

June 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

August 20, 2019

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 24, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 24, 2021

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

1.8 years

First QC Date

June 27, 2019

Last Update Submit

July 20, 2023

Conditions

Women Age 35+ Qualifies if >15% Lifetime Risk of Breast Cancer as Defined by IBIS Version 8

Keywords

increased risk of breast cancer

Outcome Measures

Primary Outcomes (2)

  • Genetic mutations

    Number of subjects to have a pathogenic/likely pathogenic mutations (Positive test result on Proactive Cancer Screening Panel)

    One year

  • Study Participants

    Number of subjects who decide to undergo genetic panel testing

    One year

Study Arms (1)

Women at intermediate/high risk of breast cancer

EXPERIMENTAL

Women age 35 years old identified at intermediate/high risk of breast cancer will receive genetic testing

Genetic: Genetic Testing

Interventions

Genetic TestingGENETIC

A blood draw or saliva kit will be provided to collect subject cells

Women at intermediate/high risk of breast cancer

Eligibility Criteria

Age35 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women participating in IRB:18-010601
  • Aged 35 and over with a negative routine mammogram within 3 months.
  • Qualifies as intermediate or high-risk (\>15% lifetime risk of breast cancer as defined by IBIS version 8).
  • Have an active email address for survey completion

You may not qualify if:

  • Not participating in the Mayo Clinic CEDM pilot (IRB: 18-010601)
  • Known genetic cancer syndrome with test results available for review in Mayo EMR
  • Known breast cancer
  • Unable to understand or sign informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Related Links

MeSH Terms

Interventions

Genetic Testing

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesGenetic TechniquesGenetic ServicesHealth ServicesHealth Care Facilities Workforce and ServicesDiagnostic ServicesPreventive Health Services

Study Officials

  • N. Jewel Samadder, MD

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 1, 2019

Study Start

August 20, 2019

Primary Completion

May 24, 2021

Study Completion

May 24, 2021

Last Updated

July 24, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)