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Trial record 9 of 88751 for:    testing

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03081455
Recruitment Status : Completed
First Posted : March 16, 2017
Last Update Posted : August 8, 2017
Sponsor:
Collaborator:
Myriad Genetics, Inc.
Information provided by (Responsible Party):
Myriad Genetic Laboratories, Inc.

Tracking Information
First Submitted Date March 1, 2017
First Posted Date March 16, 2017
Last Update Posted Date August 8, 2017
Actual Study Start Date February 13, 2017
Actual Primary Completion Date July 7, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 10, 2017)
The percentage of previously untested patients meeting guidelines who are offered genetic testing on site. [ Time Frame: Baseline ]
The percentage of previously untested patients meeting guidelines who are offered genetic testing on site.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03081455 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: March 10, 2017)
The number of previously untested patients meeting guidelines who agree to undergo genetic testing without a pre-test referral to a genetic counselor. [ Time Frame: Baseline ]
The number of previously untested patients meeting guidelines who agree to undergo genetic testing without a pre-test referral to a genetic counselor.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Impact of a Process Intervention on Screening and Testing Outcomes for Common Hereditary Cancer Syndromes
Official Title A Prospective Evaluation of the Impact of a Process Engineering Intervention on Screening and Testing Outcomes for Common Hereditary Cancer Syndromes in Community-Based Obstetrics and Gynecology Settings
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.
Detailed Description This is a prospective process intervention study that will compare historical pre-process intervention data to post-intervention data from study providers within participating community obstetrics and gynecology practices. This study will begin with a process intervention at the participating practices during which Myriad Genetics personnel experienced in implementation of hereditary cancer risk assessment programs will provide training to practice providers. The training will be followed by a 4-week practice period to allow for incorporation of the recommendations of the intervention process into the practice. During a subsequent 8-week Observation period, women who present for an office visit (new patient visit, well women visit, or problem visit) will be screened for common hereditary cancer syndromes following the process established during the process intervention. Patients who meet NCCN/ACOG testing guidelines will be offered genetic testing. Patients and study providers will be surveyed about their satisfaction with the hereditary cancer risk assessment process.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood and saliva
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.
Condition Hereditary Cancer
Intervention Diagnostic Test: Diagnostic Test
Genetic Diagnostic Testing
Study Groups/Cohorts 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.
Intervention: Diagnostic Test: Diagnostic Test
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 7, 2017)
145
Original Estimated Enrollment
 (submitted: March 10, 2017)
500
Actual Study Completion Date August 4, 2017
Actual Primary Completion Date July 7, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03081455
Other Study ID Numbers PC-005
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Disclosed via peer-reviewed journal
Responsible Party Myriad Genetic Laboratories, Inc.
Study Sponsor Myriad Genetic Laboratories, Inc.
Collaborators Myriad Genetics, Inc.
Investigators
Study Director: Rocye T. Adkins, MD Myriad Genetics, Inc.
PRS Account Myriad Genetic Laboratories, Inc.
Verification Date August 2017