Impact of a Process Intervention on Screening and Testing Outcomes for Common Hereditary Cancer Syndromes

NCT03081455 | Completed

• 1 other identifier: PC-005
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 2

Brief Summary

A prospective, non-interventional study to evaluate the impact of a process engineering intervention on screening and testing outcomes for common hereditary cancer syndromes in community-based OB/GYN settings.

Conditions

Hereditary Cancer

Keywords

Screening; Hereditary Cancer

Outcome Measures

Primary Outcomes (1)

• The percentage of previously untested patients meeting guidelines who are offered genetic testing on site.

  The percentage of previously untested patients meeting guidelines who are offered genetic testing on site.

  Baseline

Secondary Outcomes (1)

• The number of previously untested patients meeting guidelines who agree to undergo genetic testing without a pre-test referral to a genetic counselor.

  Baseline

Study Arms (1)

Women meeting guidelines for genetic testing

Women who present for an OB/GYN office visit (new patient visit, well woman visit, or problem visit) and who meet guidelines for genetic diagnostic testing will provide a blood or saliva sample for genetic diagnostic testing and complete a satisfaction survey.

Diagnostic Test: Diagnostic Test

Interventions

Diagnostic Test DIAGNOSTIC_TEST

Genetic Diagnostic Testing

Women meeting guidelines for genetic testing

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women presenting for a well woman visit, new patient visit, or problem visit at participating OB/GYN practices during the 8-week Observation Period.

You may qualify if:

• Patient who presents for a new patient gynecologic visit, well woman exam, or problem gynecologic visit and meets guidelines (HBOC-NCCN guidelines; Lynch syndrome-SGO/ACOG guidelines) for genetic testing
• Patient who is 18 years of age or older
• Able to understand informed consent and agrees to participate

You may not qualify if:

• Patient who has previously undergone BRCA1/2, Lynch syndrome genetic testing, or multi-gene, pan-cancer, or panel testing
• Patient who is not pregnant
• Patient who is unwilling or unable to provide informed consent.

Sponsors & Collaborators

• Myriad Genetic Laboratories, Inc.: lead
• Myriad Genetics, Inc.: collaborator

Study Sites (2)

Westwood Women's Health

Waterbury, Connecticut, 06708, United States

Location

Associates for Women's Medicine

Syracuse, New York, 13203, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood and saliva

MeSH Terms

Interventions

Diagnostic Tests, Routine

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Rocye T. Adkins, MD

  Myriad Genetics, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 16, 2017
• Study Start: February 13, 2017
• Primary Completion: July 7, 2017
• Study Completion: August 4, 2017
• Last Updated: August 8, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

US (2)