Ohio Colorectal Cancer Prevention Initiative



Status:Completed
Conditions:Colorectal Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:6/30/2018
Start Date:December 26, 2012
End Date:January 2, 2018

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Ohio Colorectal Cancer Prevention Initiative: Universal Screening for Lynch Syndrome

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.

Lynch Syndrome:

Lynch syndrome (LS), previously known as "hereditary non-polyposis colorectal cancer", is a
hereditary cancer syndrome that causes the majority of hereditary CRC and approximately 3% of
all CRC. LS significantly increases the risk for an individual to develop CRC during their
lifetime. Individuals with LS also have an increased risk to develop extracolonic cancers,
including endometrial, gastric, ovarian, upper urinary tract, small bowel, biliary tract,
CNS, and certain types of skin cancer. Tumor studies, including microsatellite instability
(MSI) testing and immunohistochemical (IHC) analysis, provide information regarding
characteristic features of LS-associated tumors and can help target genetic testing. Given
the hereditary nature of this syndrome, screening all patients who are newly diagnosed with
CRC for LS can identify additional individuals who are at high-risk of developing cancer.

Study Aims:

By developing a CRC research infrastructure within the state of Ohio, the OCCPI will achieve
the following specific aims:

- Establish and implement a statewide universal screening protocol for LS.

- Elucidate the prevalence of hereditary CRC in Ohio.

- Provide screening recommendations for high-risk individuals with CRC and their families,
as well as local access to genetic counseling.

- Create a CRC biorepository for future research on the etiology of CRC from the leftover
samples of the CRC patients, as well as samples from their relatives.

With the successful implementation of the OCCPI, knowledge will be gained that will
facilitate the adoption of a universal screening protocol for LS in Ohio and the creation of
a statewide CRC biorepository to be used for additional studies on cancer risks, prevention,
screening, treatment and survivorship.

Study Procedures for CRC and EC participants:

- You will be asked to donate 2-3 tablespoons of blood.

- A small piece of your colorectal or endometrial tumor will be obtained from the hospital
where you had your surgery.

- You will be asked to contribute your leftover samples (tumor and blood) to the OCCPI
biorepository (sample bank) for help with future research. Additionally, CRC
participants will be asked to donate a saliva sample to the OCCPI biorepository. The
samples will be kept securely in a lab at OSU. Before your samples can be used for
research, the people doing the research must get specific approval from the OCCPI
Steering Committee and possibly the Institutional Review Board (IRB) of OSU. The IRB is
responsible for protecting the participants involved in research studies and making sure
all research is done in a safe and ethical manner.

- You will be asked to complete a questionnaire which will ask about your age, medical
history, family history, lifestyle factors and environmental exposures. It should take
about one hour to complete the questionnaire and you can complete it from home.

- We will test your tumor for features of LS (MSI, IHC, methylation).

- For CRC patients: if your tumor shows features of LS OR you were diagnosed under age 50
OR you have a family history of CRC or endometrial cancer OR you have synchronous or
metachronous CRC or endometrial cancer, we will test your blood for the genes that cause
LS, as well as other genes that can cause hereditary cancer.

- For endometrial cancer patients: if your tumor shows features of LS, we will test your
blood for the genes that cause LS, as well as other genes that can cause hereditary
cancer.

- Some patients may have tumor genetic testing.

- If you are found to have LS or another type of hereditary cancer, you will be offered
free genetic counseling.

- If you are found to have LS, your at-risk relatives will be offered free genetic
counseling and genetic testing.

Study Procedures for first-degree relatives (FDR) of the CRC participants:

The FDRs of all of the CRC study participants will be given the opportunity to contribute to
the biorepository for future research.

- Family Member Consent for Contact forms will be provided to the CRC participant at the
time of their enrollment for them to distribute to all of their FDRs (parents, siblings
and adult children ≥ 25 years). The FDRs will mail the signed form to OSU.

- After obtaining permission to contact the FDRs, OSU will mail them the biorepository
consent form and saliva kit to return to the OCCPI biorepository.

- The FDRs of the CRC study participants will also be invited to complete the baseline
questionnaire.

Length of study:

- The LS tumor screening portion of the OCCPI will take 1-4 months.

- If applicable, genetic testing results should be ready in an additional 3-6 months.

- Overall, your participation in the LS screening portion of the OCCPI is expected to take
about 1 year. Most of this time will be spent waiting for results. Your active
involvement will take about 15 minutes on the day that you provide consent and about 60
minutes when you complete the questionnaire from home.

Inclusion Criteria:

1. Newly diagnosed with colorectal adenocarcinoma (all stages) and have a resection at
any hospital in Ohio between 1/1/2013 and 12/31/2016.

- For individuals who have neoadjuvant treatment and show a complete response at
resection, the tumor screening will be attempted on their original biopsy (even
if it occurred in 2012) as long as their resection occurred between 1/1/2013 and
12/31/2016.

- Many individuals with stage IV CRC will not have a resection; therefore, the
tumor screening will be attempted on their original colon biopsy as long as their
primary diagnosis occurred between 1/1/2013 and 12/31/2016. If only metastatic
CRC is available on a biopsy (liver or lymph node metastases), tumor screening
will be attempted on the metastatic tissue.

2. Newly diagnosed with endometrial cancer (any histology except sarcoma) and have a
resection between 1/1/2013 and 12/31/2016 at OSU only.

3. All at-risk relatives of the participants found to have LS.

4. First-degree relatives (parents, siblings and adult children ≥ 25 years of age) of the
CRC participants who do not have LS.

Exclusion Criteria:

1. Prisoners.

2. Individuals who are under the age of 18.

3. Individuals must have a primary colorectal or endometrial cancer, not a recurrence of
a previous colorectal or endometrial cancer.
We found this trial at
49
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Cincinnati, Ohio
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9500 Euclid Avenue
Cleveland, Ohio 44106
216.444.2200
Principal Investigator: Matthew Kalady, MD
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
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1 Akron General Ave
Akron, Ohio 44307
(330) 344-6000
Akron General Medical Center It
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Akron, Ohio 44309
Principal Investigator: Sameer Mahesh, MD
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Barberton, Ohio 44203
Principal Investigator: Sameer Mahesh, MD
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3000 Hospital Drive
Batavia, Ohio 45103
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Canton, Ohio 44708
Principal Investigator: Gregory Manson, MD
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Canton, Ohio 44710
Principal Investigator: Kisa Weeman, MD
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ChillIcothe, Ohio 45601
Principal Investigator: Philip Kuebler, MD
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2139 Auburn Ave
Cincinnati, Ohio 45219
(513) 585-2000
Principal Investigator: Ian Paquette, MD
The Christ Hospital For more than 120 years, The Christ Hospital has been a leader...
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Cincinnati, Ohio 45220
Principal Investigator: Scott Kelley, MD
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Cincinnati, Ohio 45242
Principal Investigator: Scott Kelley, MD
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Cincinnati, Ohio
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Cincinnati, Ohio 45236
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Cleveland, Ohio 44109
Principal Investigator: Timothy O'Brien, MD
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Cleveland, Ohio 44111
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Columbus, Ohio 43213
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Columbus, Ohio 43222
Principal Investigator: Philip Kuebler, MD
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5100 W Broad St
Columbus, Ohio 43228
(614) 544-1000
Principal Investigator: Philip Kuebler, MD
Doctors Hospital Nationally recognized for care quality and patient safety and satisfaction, Doctors Hospital is...
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3535 Olentangy River Rd
Columbus, Ohio 43214
(614) 566-5000
Principal Investigator: Philip Kuebler, MD
Riverside Methodist Hospital Serving central Ohio since 1892, Riverside Methodist Hospital is consistently ranked one...
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111 S Grant Ave
Columbus, Ohio 43215
(614) 566-9000
Principal Investigator: Philip Kuebler, MD
Grant Medical Center Founded in 1900 in Columbus' downtown, Grant has grown into one of...
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Cuyahoga Falls, Ohio 44223
Principal Investigator: Sameer Mahesh, MD
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
Principal Investigator: Howard Gross, MD
Miami Valley Hospital Miami Valley Hospital (MVH) is passionate about providing the most recent medical...
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Dayton, Ohio 45429
Principal Investigator: Howard Gross, MD
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2222 Philadelphia Dr
Dayton, Ohio 45406
(937) 734-2612
Principal Investigator: Howard Gross, MD
Good Samaritan Hospital - Dayton Good Samaritan Hospital (GSH) is passionate about providing the most...
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Dayton, Ohio 45433
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561 W. Central Avenue
Delaware, Ohio 43015
(740) 615-1000
Principal Investigator: Philip Kuebler, MD
Grady Memorial Hospital As the center of healthcare in Delaware County, Grady Memorial Hospital is...
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Fairfield, Ohio
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Findlay, Ohio 45840
Principal Investigator: Howard Gross, MD
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Greenville, Ohio 45331
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401 N Ewing St
Lancaster, Ohio 43130
(740) 687-8000
Fairfield Medical Center We are people you know offering care you trust. Serving more than...
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730 W Market St
Lima, Ohio 45801
(419) 227-3361
St. Rita's Medical Center Welcome to St. Rita's Medical Center. As the region's leader in...
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401 Matthew St
Marietta, Ohio 45750
(740) 374-1455
Principal Investigator: Philip Kuebler, MD
Marietta Memorial Hospital We are 2,600 strong and the county
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1000 McKinley Park Drive
Marion, Ohio 43302
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Maumee, Ohio 43537
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5805 Monclova Road
Maumee, Ohio 43537
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Mayfield Heights, Ohio 44124
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Middletown, Ohio 45005
Principal Investigator: Howard Gross, MD
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1330 Coshocton Ave
Mount Vernon, Ohio 43050
(740) 393-9000
Principal Investigator: Philip Kuebler, MD
Knox Community Hospital A community-owned, 115-bed, not-for-profit hospital located in Mount Vernon, Ohio (approximately 40...
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1320 W Main St
Newark, Ohio 43055
(740) 348-4000
Principal Investigator: Philip Kuebler, MD
Licking Memorial Hospital Licking Memorial Health Systems (LMHS) is a not-for-profit health care organization dedicated...
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1805 27th St
Portsmouth, Ohio 45662
(740) 356-5000
Principal Investigator: Philip Kuebler, MD
Southern Ohio Medical Center Southern Ohio Medical Center (SOMC) is a 222-bed 501(C)(3) not-for-profit hospital...
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Ravenna, Ohio 44266
Principal Investigator: Sameer Mahesh, MD
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100 North St
Springfield, Ohio 45502
(937) 523-1000
Principal Investigator: Philip Kuebler, MD
Springfield Regional Medical Center When it comes to your family
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Sylvania, OH
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3130 N. County Rd. 25-A
Troy, Ohio 45373
(937) 440-4000
Principal Investigator: Howard Gross, MD
Upper Valley Medical Center Upper Valley Medical Center (UVMC) is a not-for-profit health care provider...
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Warrensville Heights, Ohio 44122
Phone: 216-491-0128
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Westerville, Ohio 43081
Principal Investigator: Philip Kuebler, MD
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Zanesville, Ohio 43701
Principal Investigator: Philip Kuebler, MD
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