Clincosm LogoSign in Get a demo

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

Sponsor
Data Collection Analysis Business Management (Other)
Overall Status
Unknown status
CT.gov ID
NCT03319290
Collaborator
PAS Research Services (Other)
2,000
Enrollment
1
Location
36
Anticipated Duration (Months)
55.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Genetic: BRCA1 and BRCA2

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 Design

Study Type:
Observational
Actual Enrollment :
2000 participants
Observational Model:
Other
Time Perspective:
Cross-Sectional
Official Title:
Medical Provider Experience Assessment Healthcare Decisions Post-Testing, Risk Reducing, and Preventative Strategies Using BRCA2 and BRCA2 Genetic Testing
Actual Study Start Date :
Oct 17, 2017
Anticipated Primary Completion Date :
Oct 1, 2020
Anticipated Study Completion Date :
Oct 17, 2020

Outcome Measures

Primary Outcome Measures

  1. Provider Structures and Processes [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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 DCABM Land O' Lakes Florida United States 33558

Sponsors and Collaborators

  • Data Collection Analysis Business Management
  • PAS Research Services

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Data Collection Analysis Business Management
ClinicalTrials.gov Identifier:
NCT03319290
Other Study ID Numbers:
  • PAS1460
First Posted:
Oct 24, 2017
Last Update Posted:
Jan 23, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 23, 2019