Ohio Colorectal Cancer Prevention Initiative

NACompletedINTERVENTIONAL
Enrollment

3,470

Participants

Timeline

Start Date

December 26, 2012

Primary Completion Date

January 2, 2018

Study Completion Date

January 2, 2018

Conditions
Lynch SyndromeColorectal 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

Trial Locations (49)

43015

Grady Memorial Hospital, Delaware

43050

Knox Community Hospital, Mount Vernon

43055

Licking Memorial Hospital, Newark

43081

Mount Carmel St. Ann's Hospital, Westerville

43130

Fairfield Medical Center, Lancaster

43213

Mount Carmel East Hospital, Columbus

43214

Riverside Methodist Hospital, Columbus

43215

Grant Medical Center, Columbus

43222

Mount Carmel West Hospital, Columbus

43228

Doctors Hospital, Columbus

43537

St. Luke's Hospital (ProMedica), Maumee

43560

Flower Hospital (ProMedica Health System), Sylvania

43606

Toledo Hospital (Promedica Health System), Toledo

43701

Genesis Cancer Care Center (Genesis Healthcare System), Zanesville

44109

Akron General Medical Center, Akron

MetroHealth, Cleveland

44111

Fairview Hospital, Cleveland

44124

Hillcrest Hospital, Mayfield Heights

44195

Cleveland Clinic, Cleveland

44203

Summa Barberton (Summa Health System), Barberton

44223

Summa Western Reserve (Summa Health System), Cuyahoga Falls

44266

Robinson Memorial (Summa Health System), Ravenna

44309

Akron City/St. Thomas Hospital (Summa Health System), Akron

44708

Mercy Medical Center, Canton

44710

Aultman Hospital, Canton

45005

Atrium Medical Center, Middletown

45219

The Christ Hospital, Cincinnati

45220

Good Samaritan Hospital (TriHealth), Cincinnati

45242

Bethesda North Hospital (TriHealth), Cincinnati

45331

Wayne Healthcare, Greenville

45373

Upper Valley Medical Center, Troy

45409

Miami Valley Hospital, Dayton

45415

Good Samaritan Hospital Dayton, Dayton

45429

Kettering Medical Center, Dayton

45433

Wright-Patterson Medical Center, Dayton

45504

Springfield Regional Medical Center, Springfield

45601

Adena Health System, Chillicothe

45648

Southern Ohio Medical Center, Portsmouth

45750

Marietta Memorial Hospital, Marietta

45801

St. Rita's Medical Center, Lima

45840

Blanchard Valley Health System, Findlay

Unknown

Mercy Clermont, Batavia

Mercy Anderson, Cincinnati

Mercy West, Cincinnati

The Jewish Hospital, Cincinnati

Mercy Fairfield, Fairfield

Marion General Hospital, Marion

Toledo Clinic Cancer Center, Maumee

South Pointe Hospital, Warrensville Heights

All Listed Sponsors
lead

Ohio State University Comprehensive Cancer Center

OTHER

NCT01850654 - Ohio Colorectal Cancer Prevention Initiative | Biotech Hunter | Biotech Hunter