Predictive Genetic Risk Assessment Trial (PGT)

This study has been completed.
Information provided by:
Mayo Clinic Identifier:
First received: October 29, 2008
Last updated: April 25, 2011
Last verified: April 2011
This proof-of-principle clinical trial at Mayo Clinic studies how patients and their physicians understand and utilize predictive genetic risk assessment. A critical goal of this clinical trial is to understand how individual patients and their doctors perceive and respond to genetic risk information that is largely uncertain.

Condition Intervention
Colon Cancer
Lung Cancer
Atrial Fibrillation
Diabetes Type 2
Breast Cancer
Graves Disease
Celiac Disease
Myocardial Infarction
Prostate Cancer
Genetic: SNP analysis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Proof-of-Principle Trial of Communication to Patients Receiving Predictive Genetic Risk Assessment

Resource links provided by NLM:

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Assess accessibility and feasibility, including positive and negative aspects of integrating predictive genomics at the clinic focusing on patients' and physicians' attitudes [ Time Frame: March 2008-March 2009 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess effects of predictive genomics on self-reported health behavior and on physician-patient interaction [ Time Frame: March 2008-March 2009 ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: March 2008
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Genetic Testing Group
Those who will receive predictive genetic risk assessments
Genetic: SNP analysis
The patients in the intervention group will obtain genetic risk assessments based on genome-wide association studies.
Other Name: Navigenics
Those who will receive standard of care

  Show Detailed Description


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients and physicians from the Mayo Clinic Rochester Executive Health (EH) program will be recruited to participate in this study

Inclusion Criteria:

  • must be established EH patient or physician

Exclusion Criteria:

  • pregnant women
  • patient who have already purchased Navigenics Health Compass
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00782366

United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Study Director: Kristina Tiedje, Ph.D. Mayo Clinic
Principal Investigator: Clayton T. Cowl, M.D. Mayo Clinic
Principal Investigator: Barbara A. Koenig, Ph.D. Mayo Clinic
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Clayton T. Cowl, M.D., Mayo Clinic Identifier: NCT00782366     History of Changes
Other Study ID Numbers: 07-007414 
Study First Received: October 29, 2008
Last Updated: April 25, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
predictive genomics
personalized medicine
personal genomics
direct-to-consumer genetic testing
genetic knowledge
genetic attitudes

Additional relevant MeSH terms:
Graves Disease
Atrial Fibrillation
Celiac Disease
Diabetes Mellitus, Type 2
Myocardial Infarction
Arrhythmias, Cardiac
Autoimmune Diseases
Cardiovascular Diseases
Diabetes Mellitus
Digestive System Diseases
Endocrine System Diseases
Eye Diseases
Gastrointestinal Diseases
Glucose Metabolism Disorders
Heart Diseases
Immune System Diseases
Intestinal Diseases
Malabsorption Syndromes
Metabolic Diseases
Myocardial Ischemia
Orbital Diseases
Pathologic Processes
Thyroid Diseases
Vascular Diseases processed this record on April 27, 2016