Predictive Genetic Risk Assessment Trial (PGT)
This study has been completed.
Sponsor:
Mayo Clinic
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00782366
First received: October 29, 2008
Last updated: April 25, 2011
Last verified: April 2011
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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:
MedlinePlus related topics:
Atrial Fibrillation
Breast Cancer
Cancer
Celiac Disease
Diabetes
Diabetes Type 2
Genetic Testing
Heart Attack
Lung Cancer
Obesity
Osteoarthritis
Prostate Cancer
U.S. FDA Resources
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
|
|
Control
Those who will receive standard of care
|
Show Detailed Description Eligibility| 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
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided by Mayo Clinic
Additional 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 |
| 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:
|
Atrial Fibrillation Breast Neoplasms Colonic Neoplasms Celiac Disease Diabetes Mellitus, Type 2 Graves Disease Infarction Lung Neoplasms Myocardial Infarction Obesity Osteoarthritis Prostatic Neoplasms Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases |
Pathologic Processes Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Malabsorption Syndromes Metabolic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013