Ohio Colorectal Cancer Prevention Initiative

Summary

The purpose of the Ohio Colorectal Cancer Prevention Initiative (OCCPI) is to reduce morbidity and mortality due to colorectal cancer (CRC) in the state of Ohio. By identifying individuals at high-risk for CRC (genetically predisposed) and providing screening recommendations for cancer risk reduction, the OCCPI will understand how to increase length of life and quality of life for those diagnosed with CRC in Ohio, as well as to better prevent CRC in others in Ohio.

Participants will have free tumor screening for Lynch syndrome, and may be eligible for free genetic testing and free genetic counseling as part of this study.

Conditions

• Lynch Syndrome
• Colorectal Cancer

Interventions

GENETIC

LS tumor screening

All participants with CRC or EC will have LS tumor screening (MSI, IHC, methylation if applicable).

GENETIC

Genetic testing

Next-generation sequencing panel of several genes that increase the risk for hereditary cancers including the LS genes (MLH1, MSH2, MSH6, PMS2, EPCAM), polyposis genes (MUTYH, APC), and others. The following study participants will have free genetic testing: * CRC and EC study participants with unmethylated MSI-high (MSI-H) tumors * CRC and EC study participants with microsatellite stable (MSS) or MSI-low (MSI-L) tumors who have abnormal IHC results and they do not have methylation of the MLH1 promoter * CRC study participants diagnosed with CRC \<50 years, regardless of tumor studies or family history * CRC study participants diagnosed with CRC ≥ 50 years with a FDR with CRC or EC OR synchronous or metachronous CRC or EC throughout their life, regardless of tumor studies. At-risk relatives of the individuals found to have LS are eligible for free single site genetic testing.

BEHAVIORAL

Genetic Counseling

The participants found to have LS or another type of hereditary cancer will have free genetic counseling. At-risk relatives of the individuals found to have LS are eligible for free genetic counseling.

OTHER

Biorepository

The biorepository is an optional part of the OCCPI. CRC and EC participants will contribute leftover tumor and blood samples, as well as a saliva sample. FDR of the CRC participants will contribute a saliva sample. The at-risk relatives of those found to have LS will contribute blood and saliva samples.

BEHAVIORAL

Questionnaire

Sponsors & Collaborators

• Ohio State University Comprehensive Cancer Center

  lead OTHER

Principal Investigators

• Heather Hampel, MS, LGC · Ohio State University Comprehensive Cancer Center

Study Design

Allocation

NON_RANDOMIZED

Purpose

SCREENING

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-12-26

Primary Completion

2018-01-02

Completion

2018-01-02

Countries

• United States

Study Locations