Clinical trial · Interventional
Genetic Epidemiology Risk Assessment Program or Usual Care in Colorectal Cancer Screening for Healthy Participants
Gene Environment Risk Assessment and CRC Screening
NCT00478309CI-TRIAL-00021222completedN/AClinicalTrials.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)
RATIONALE: The Genetic Epidemiology and Risk Assessment program may be more effective than usual care in increasing the number of healthy participants who regularly receive screening for colorectal cancer. PURPOSE: This randomized clinical trial is studying the Genetic Epidemiology and Risk Assessment program to see how well it works compared with usual care to increase colorectal cancer screening in healthy participants.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Healthy, no Evidence of Disease | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| counseling intervention | Other | — | UNRESOLVED |
| educational intervention | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Arm I
- description
- Participants receive standard primary care.
- type
- EXPERIMENTAL
- label
- Arm II
- description
- Participants receive standard primary care followed by the Genetic Epidemiology and Risk Assessment (GERA) intervention. Participants also participate in a discussion session regarding the GERA including the rationale behind methylenetetrahydrofolate reductase mutation detection and folate assessment and its relationship to colorectal cancer risk.
- interventionNames
- Other: counseling intervention
- Other: educational intervention
Primary outcomes (4)
- measure
- Comparison of Genetic Epidemiology and Risk Assessment (GERA) feedback vs usual care (UC) in terms of colorectal cancer (CRC) screening utilization
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Healthy participants meeting the following criteria: * No personal history of colorectal polyps or cancer or inflammatory bowel disease * No family history of familial adenomatous polyposis, hereditary nonpolyposis colorectal cancer (CRC), or CRC in more than 1 first-degree relative * Nonadherent with standard CRC screening recommendations at the time of their index office visit PATIENT CHARACTERISTICS: * Able to communicate with ease in English PRIOR CONCURRENT THERAPY: * More than 6 weeks since prior antibiotics or antifolate medications (e.g., sulfasalazine, methotrexate)
References
Publications (1)
- RESULTMyers RE, Manne SL, Wilfond B, Sifri R, Ziring B, Wolf TA, Cocroft J, Ueland A, Petrich A, Swan H, DiCarlo M, Weinberg DS. A randomized trial of genetic and environmental risk assessment (GERA) for colorectal cancer risk in primary care: trial design and baseline findings. Contemp Clin Trials. 2011 Jan;32(1):25-31. doi: 10.1016/j.cct.2010.08.013. Epub 2010 Sep 7. PMID 20828635