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

Hereditary Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03319290
• Other study ID #: PAS1460
• Status: Enrolling by invitation
• Start date: October 17, 2017
• Est. completion date: October 17, 2020

Study information

• Verified date: January 2019
• Source: Data Collection Analysis Business Management
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2000
• Est. completion date: October 17, 2020
• Est. primary completion date: October 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hereditary Cancer

Intervention

Genetic:
• BRCA1 and BRCA2
Genetic breast and ovarian cancer testing

Locations

Country	Name	City	State
United States	DCABM	Land O' Lakes	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Data Collection Analysis Business Management	PAS Research Services

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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