NCT03319290

Brief Summary

Observational study is to increase surveillance for breast and ovarian cancers, also to determine targeted risk-reducing and preventative strategies.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

October 17, 2017

Completed
Same day until next milestone

Study Start

First participant enrolled

October 17, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 24, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2020

Completed
Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

October 17, 2017

Last Update Submit

January 22, 2019

Conditions

Hereditary Cancer

Outcome Measures

Primary Outcomes (1)

  • Provider Structures and Processes

    Plan of Care Changes due to BRCA testing. Provider based observational survey system on the health and well-being of patients and populations

    36 months

Interventions

BRCA1 and BRCA2GENETIC

Genetic breast and ovarian cancer testing

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Current standard operating procedures for providers

You may qualify if:

  • Must be a Medical Practitioner
  • Medical Doctor (MD)
  • Doctor of Osteopathic (DO)
  • Physician Assistant (PA)
  • Advanced Practice Registered Nurse (APRN)
  • Nurse Practitioner (NP)
  • Must have a current standard operating procedure that includes obtaining/reviewing medical history and family medical history

You may not qualify if:

  • Government-funded insurance data cannot be included in the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DCABM

Land O' Lakes, Florida, 33558, United States

Location

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 17, 2017

First Posted

October 24, 2017

Study Start

October 17, 2017

Primary Completion

October 1, 2020

Study Completion

October 17, 2020

Last Updated

January 23, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)