Integrating Genetic Testing for Lynch Syndrome in a Managed Care Setting

NCT01582841 | Completed

• 1 other identifier: 1R01CA140377-01A2
• Study Type: interventional
• Target: 247
• Locations: 1 country
• Sites: 1

Brief Summary

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

Colon Cancer; Lynch Syndrome

Keywords

Colon Cancer; Lynch Syndrome; Genetic Screening

Outcome Measures

Primary Outcomes (1)

• Implementation effectiveness

  The primary outcomes to assess implementation effectiveness are: number of patients who receive HNPCC screening test results; number of physicians who receive their patients HPNCC screening test results; completion of the educational session at three months of follow-up; and number of patients with MSI-H (microsatellite instability-high) test results who are contacted by medical genetics.

  All patients will be followed up to 5 years. Most active participation and chart review will take place within one year of surgery.

Study Arms (2)

MSI testing

EXPERIMENTAL

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.

Procedure: MSI screening test

Usual care

NO INTERVENTION

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.

Interventions

MSI screening test PROCEDURE

All individuals in the intervention arm who consent to participate in the HNPCC screening will have their tumors evaluated for MSI.

MSI testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old
• Kaiser Permanente member
• Referral or scheduled colon surgery
• No known cognitive impairments (e.g., Alzheimer's Disease) that would impact the ability to be consented
• English speaker
• Diagnosis of colon cancer

You may not qualify if:

• Under the age of 18
• Known cognitive impairment
• Inability to speak/understand English
• Known Lynch syndrome
• No diagnosis of colon cancer
• In hospice

Sponsors & Collaborators

• Kaiser Permanente: lead
• Case Western Reserve University: collaborator
• M.D. Anderson Cancer Center: collaborator
• Dana-Farber Cancer Institute: collaborator
• Vanderbilt University: collaborator

Study Sites (1)

Kaiser Permanente Northwest

Portland, Oregon, 97227, United States

Location

MeSH Terms

Conditions

Colonic Neoplasms; Colorectal Neoplasms, Hereditary Nonpolyposis

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; DNA Repair-Deficiency Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Katrina AB Goddard, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2011
• First Posted: April 23, 2012
• Study Start: February 1, 2012
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: August 31, 2016

Record last verified: 2016-08

Locations

US (1)