Predictive Genetic Risk Assessment Trial - Full Text View

Sponsored by:	Mayo Clinic
Information provided by:	Mayo Clinic
ClinicalTrials.gov Identifier:	NCT00782366

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

Genetics Home Reference related topics: breast cancer Brugada syndrome familial atrial fibrillation short QT syndrome

MedlinePlus related topics: Breast Cancer Cancer Celiac Disease Diabetes Heart Attack Lung Cancer Obesity Osteoarthritis Prostate Cancer

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	170
Study Start Date:	March 2008
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	March 2009 (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.
Control Those who will receive standard of care

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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

Mayo Clinic Clinical Trials This link exits the ClinicalTrials.gov site

Responsible Party:	Mayo Clinic ( Clayton T. Cowl, M.D. )
Study ID Numbers:	07-007414
Study First Received:	October 29, 2008
Last Updated:	October 29, 2008
ClinicalTrials.gov Identifier:	NCT00782366
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

Study placed in the following topic categories:

Thoracic Neoplasms
Prostatic Diseases
Colonic Diseases
Urogenital Neoplasms
Body Weight
Lung Neoplasms
Nutrition Disorders
Breast Diseases
Hyperthyroidism
Digestive System Neoplasms
Heart Diseases
Metabolic Diseases
Breast Neoplasms
Endocrine System Diseases
Ischemia

Graves' disease
Genital Diseases, Male
Lung Diseases
Gastrointestinal Neoplasms
Celiac Disease
Orbital Diseases
Metabolic disorder
Infarction
Prostatic Neoplasms
Colonic Neoplasms
Arrhythmias, Cardiac
Genital Neoplasms, Male
Gastrointestinal Diseases
Osteoarthritis
Myocardial Ischemia

Additional relevant MeSH terms:

Respiratory Tract Neoplasms
Neoplasms
Neoplasms by Site
Pathologic Processes

Immune System Diseases
Cardiovascular Diseases
Exophthalmos

ClinicalTrials.gov processed this record on January 16, 2009