Clinical trial · Interventional
Integrating Genetic Testing for Lynch Syndrome in a Managed Care Setting
NCT01582841CI-TRIAL-00023720HNPCCcompletedN/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)
The investigators research mobilizes the resources of an integrated health-delivery system with extensive electronic clinical data to implement and evaluate a new strategy to maximize screening of Colorectal Cancer (CRC) patients for Lynch Syndrome.
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 |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Lynch Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MSI screening test | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MSI testing
- description
- All individuals in the intervention arm who consent to participate in the HNPCC screening will have their tumors evaluated for MSI following surgery. Those with MSI-H results will receive a genetic counseling informational call.
- interventionNames
- Procedure: MSI screening test
- type
- NO_INTERVENTION
- label
- Usual care
- description
- These patients will be treated as usual by their oncologist and medical team. These patients receive a follow up letter a year after randomization, alerting them to the availability of clinical Lynch Syndrome screening.
Primary outcomes (1)
- measure
- Implementation effectiveness
- timeFrame
- All patients will be followed up to 5 years. Most active participation and chart review will take place within one year of surgery.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. At least 18 years old 2. Kaiser Permanente member 3. Referral or scheduled colon surgery 4. No known cognitive impairments (e.g., Alzheimer's Disease) that would impact the ability to be consented 5. English speaker 6. Diagnosis of colon cancer Exclusion Criteria: 1. Under the age of 18 2. Known cognitive impairment 3. Inability to speak/understand English 4. On the research exclusion list 5. Known Lynch syndrome 6. No diagnosis of colon cancer 7. In hospice
References
Publications (0)
Data not yet available
No reference posted for this study.