NCT00782366

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2008

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
Last Updated

April 27, 2011

Status Verified

April 1, 2011

Enrollment Period

1.8 years

First QC Date

October 29, 2008

Last Update Submit

April 25, 2011

Conditions

Colon CancerLung CancerAtrial FibrillationDiabetes Type 2ObesityBreast CancerGraves DiseaseOsteoarthritisCeliac DiseaseMyocardial InfarctionProstate Cancer

Keywords

predictive genomicspersonalized medicinepersonal genomicsdirect-to-consumer genetic testinggenetic knowledgegenetic attitudes

Outcome Measures

Primary Outcomes (1)

  • Assess accessibility and feasibility, including positive and negative aspects of integrating predictive genomics at the clinic focusing on patients' and physicians' attitudes

    March 2008-March 2009

Secondary Outcomes (1)

  • Assess effects of predictive genomics on self-reported health behavior and on physician-patient interaction

    March 2008-March 2009

Study Arms (2)

Genetic Testing Group

Those who will receive predictive genetic risk assessments

Genetic: SNP analysis

Control

Those who will receive standard of care

Interventions

SNP analysisGENETIC

The patients in the intervention group will obtain genetic risk assessments based on genome-wide association studies.

Also known as: Navigenics
Genetic Testing Group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients and physicians from the Mayo Clinic Rochester Executive Health (EH) program will be recruited to participate in this study

You may qualify if:

  • must be established EH patient or physician

You may not qualify if:

  • pregnant women
  • patient who have already purchased Navigenics Health Compass

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

  • James KM, Cowl CT, Tilburt JC, Sinicrope PS, Robinson ME, Frimannsdottir KR, Tiedje K, Koenig BA. Impact of direct-to-consumer predictive genomic testing on risk perception and worry among patients receiving routine care in a preventive health clinic. Mayo Clin Proc. 2011 Oct;86(10):933-40. doi: 10.4065/mcp.2011.0190.

    PMID: 21964170DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsLung NeoplasmsAtrial FibrillationDiabetes Mellitus, Type 2ObesityBreast NeoplasmsGraves DiseaseOsteoarthritisCeliac DiseaseMyocardial InfarctionProstatic Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRespiratory Tract NeoplasmsThoracic NeoplasmsLung DiseasesRespiratory Tract DiseasesArrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesExophthalmosOrbital DiseasesEye DiseasesGoiterThyroid DiseasesHyperthyroidismAutoimmune DiseasesImmune System DiseasesArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesMalabsorption SyndromesMyocardial IschemiaVascular DiseasesInfarctionIschemiaNecrosisGenital Neoplasms, MaleUrogenital NeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Study Officials

  • Kristina Tiedje, Ph.D.

    Mayo Clinic

    STUDY DIRECTOR

  • Clayton T. Cowl, M.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

  • Barbara A. Koenig, Ph.D.

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 29, 2008

First Posted

October 31, 2008

Study Start

March 1, 2008

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

April 27, 2011

Record last verified: 2011-04

Locations

US(1)