Increase Surveillance for Breast and Ovarian Cancers, Also to Determine Targeted Risk-reducing and Preventative Strategies

January 22, 2019 updated by: Data Collection Analysis Business Management

Medical Provider Experience Assessment Healthcare Decisions Post-Testing, Risk Reducing, and Preventative Strategies Using BRCA2 and BRCA2 Genetic Testing

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The general design of this study is collecting data and reviewing the Principal Investigators' (P.I.) Standard Operating Procedures (SOP) on BRCA testing and changes made to their specific SOP.

Study Type

Observational

Enrollment (Actual)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Land O' Lakes, Florida, United States, 33558
        • DCABM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Current standard operating procedures for providers

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Provider Structures and Processes
Time Frame: 36 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Data Collection Analysis Business Management

Collaborators

PAS Research Services

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 17, 2017

Primary Completion (ANTICIPATED)

October 1, 2020

Study Completion (ANTICIPATED)

October 17, 2020

Study Registration Dates

First Submitted

October 17, 2017

First Submitted That Met QC Criteria

October 19, 2017

First Posted (ACTUAL)

October 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

January 23, 2019

Last Update Submitted That Met QC Criteria

January 22, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • PAS1460

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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