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Predictive Genetic Risk Assessment Trial (PGT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00782366
First Posted: October 31, 2008
Last Update Posted: April 27, 2011
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.
Information provided by:
Mayo Clinic
  Purpose
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 Obesity Breast Cancer Graves Disease Osteoarthritis 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 ]

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

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
Control
Those who will receive standard of care

  Show Detailed Description

  Eligibility

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.


Ages Eligible for Study:   18 Years to 65 Years   (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
Criteria

Inclusion Criteria:

  • must be established EH patient or physician

Exclusion Criteria:

  • pregnant women
  • patient who have already purchased Navigenics Health Compass
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00782366


Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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 ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Clayton T. Cowl, M.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT00782366     History of Changes
Other Study ID Numbers: 07-007414
First Submitted: October 29, 2008
First Posted: October 31, 2008
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:
Osteoarthritis
Atrial Fibrillation
Infarction
Myocardial Infarction
Celiac Disease
Graves Disease
Diabetes Mellitus, Type 2
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Ischemia
Necrosis
Myocardial Ischemia
Vascular Diseases
Malabsorption Syndromes
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Metabolic Diseases
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases