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Predictive Genetic Risk Assessment Trial (PGT)

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. Identifier: NCT00782366
Recruitment Status : Completed
First Posted : October 31, 2008
Last Update Posted : April 27, 2011
Information provided by:
Mayo Clinic

Brief Summary:
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 or disease Intervention/treatment
Colon Cancer Lung Cancer Atrial Fibrillation Diabetes Type 2 Obesity Breast Cancer Graves Disease Osteoarthritis Celiac Disease Myocardial Infarction Prostate Cancer Genetic: SNP analysis

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Study Type : Observational
Actual Enrollment : 26 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Proof-of-Principle Trial of Communication to Patients Receiving Predictive Genetic Risk Assessment
Study Start Date : March 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Health Checkup

Group/Cohort Intervention/treatment
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

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Assess effects of predictive genomics on self-reported health behavior and on physician-patient interaction [ Time Frame: March 2008-March 2009 ]

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00782366

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United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
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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
Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Clayton T. Cowl, M.D., Mayo Clinic Identifier: NCT00782366    
Other Study ID Numbers: 07-007414
First Posted: October 31, 2008    Key Record Dates
Last Update Posted: April 27, 2011
Last Verified: April 2011
Keywords provided by Mayo Clinic:
predictive genomics
personalized medicine
personal genomics
direct-to-consumer genetic testing
genetic knowledge
genetic attitudes
Additional relevant MeSH terms:
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Celiac Disease
Graves Disease
Atrial Fibrillation
Myocardial Infarction
Diabetes Mellitus, Type 2
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Myocardial Ischemia
Vascular Diseases
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Malabsorption Syndromes
Metabolic Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Endocrine System Diseases
Orbital Diseases
Eye Diseases
Thyroid Diseases
Autoimmune Diseases
Immune System Diseases