Clinical trial · Observational
Predictive Genetic Risk Assessment Trial
Proof-of-Principle Trial of Communication to Patients Receiving Predictive Genetic Risk Assessment
NCT00782366CI-TRIAL-00004735PGTcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atrial Fibrillation | — | UNRESOLVED | — |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Celiac Disease | — | UNRESOLVED | — |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Diabetes Type 2 | — | UNRESOLVED | — |
| Graves Disease | — | UNRESOLVED | — |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
| Myocardial Infarction | — | UNRESOLVED | — |
| Obesity | — | UNRESOLVED | — |
| Osteoarthritis | — | UNRESOLVED | — |
| Prostate Cancer | Malignant Prostate Neoplasm |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SNP analysis | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Genetic Testing Group
- description
- Those who will receive predictive genetic risk assessments
- interventionNames
- Genetic: SNP analysis
- label
- Control
- description
- Those who will receive standard of care
Primary outcomes (1)
- measure
- Assess accessibility and feasibility, including positive and negative aspects of integrating predictive genomics at the clinic focusing on patients' and physicians' attitudes
- timeFrame
- March 2008-March 2009
Secondary outcomes (1)
- measure
- Assess effects of predictive genomics on self-reported health behavior and on physician-patient interaction
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * must be established EH patient or physician Exclusion Criteria: * pregnant women * patient who have already purchased Navigenics Health Compass
References
Publications (1)
- DERIVEDJames 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 21964170