Clinical trial NCT01850654: Ohio Colorectal Cancer Prevention Initiative
Official title: Ohio Colorectal Cancer Prevention Initiative: Universal Screening for Lynch Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lynch Syndrome
Colorectal Cancer
Keywords: colorectal cancer
colon cancer
rectal cancer
endometrial cancer
Lynch syndrome
Ohio colon cancer study
OSU colon study
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 3470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Determine the Incidence of Hereditary Cancer Syndromes among Newly Diagnosed Colorectal Cancer Patients
timeFrame: 36 months (initial assessment)
Secondary outcomes:
Other outcomes:
Locations:
city: Akron
country: United States
facility: Akron General Medical Center
state: Ohio
city: Akron
country: United States
facility: Akron City/St. Thomas Hospital (Summa Health System)
state: Ohio
city: Barberton
country: United States
facility: Summa Barberton (Summa Health System)
state: Ohio
city: Batavia
country: United States
facility: Mercy Clermont
state: Ohio
city: Canton
country: United States
facility: Mercy Medical Center
state: Ohio
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Chillicothe
country: United States
facility: Adena Health System
state: Ohio
city: Cincinnati
country: United States
facility: The Christ Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Good Samaritan Hospital (TriHealth)
state: Ohio
city: Cincinnati
country: United States
facility: Bethesda North Hospital (TriHealth)
state: Ohio
city: Cincinnati
country: United States
facility: Mercy Anderson
state: Ohio
city: Cincinnati
country: United States
facility: Mercy West
state: Ohio
city: Cincinnati
country: United States
facility: The Jewish Hospital
state: Ohio
city: Cleveland
country: United States
facility: MetroHealth
state: Ohio
city: Cleveland
country: United States
facility: Fairview Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel East Hospital
state: Ohio
city: Columbus
country: United States
facility: Riverside Methodist Hospital
state: Ohio
city: Columbus
country: United States
facility: Grant Medical Center
state: Ohio
city: Columbus
country: United States
facility: Mount Carmel West Hospital
state: Ohio
city: Columbus
country: United States
facility: Doctors Hospital
state: Ohio
city: Cuyahoga Falls
country: United States
facility: Summa Western Reserve (Summa Health System)
state: Ohio
city: Dayton
country: United States
facility: Miami Valley Hospital
state: Ohio
city: Dayton
country: United States
facility: Good Samaritan Hospital Dayton
state: Ohio
city: Dayton
country: United States
facility: Kettering Medical Center
state: Ohio
city: Dayton
country: United States
facility: Wright-Patterson Medical Center
state: Ohio
city: Delaware
country: United States
facility: Grady Memorial Hospital
state: Ohio
city: Fairfield
country: United States
facility: Mercy Fairfield
state: Ohio
city: Findlay
country: United States
facility: Blanchard Valley Health System
state: Ohio
city: Greenville
country: United States
facility: Wayne Healthcare
state: Ohio
city: Lancaster
country: United States
facility: Fairfield Medical Center
state: Ohio
city: Lima
country: United States
facility: St. Rita's Medical Center
state: Ohio
city: Marietta
country: United States
facility: Marietta Memorial Hospital
state: Ohio
city: Marion
country: United States
facility: Marion General Hospital
state: Ohio
city: Maumee
country: United States
facility: St. Luke's Hospital (ProMedica)
state: Ohio
city: Maumee
country: United States
facility: Toledo Clinic Cancer Center
state: Ohio
city: Mayfield Heights
country: United States
facility: Hillcrest Hospital
state: Ohio
city: Middletown
country: United States
facility: Atrium Medical Center
state: Ohio
city: Mount Vernon
country: United States
facility: Knox Community Hospital
state: Ohio
city: Newark
country: United States
facility: Licking Memorial Hospital
state: Ohio
city: Portsmouth
country: United States
facility: Southern Ohio Medical Center
state: Ohio
city: Ravenna
country: United States
facility: Robinson Memorial (Summa Health System)
state: Ohio
city: Springfield
country: United States
facility: Springfield Regional Medical Center
state: Ohio
city: Sylvania
country: United States
facility: Flower Hospital (ProMedica Health System)
state: Ohio
city: Toledo
country: United States
facility: Toledo Hospital (Promedica Health System)
state: Ohio
city: Troy
country: United States
facility: Upper Valley Medical Center
state: Ohio
city: Warrensville Heights
country: United States
facility: South Pointe Hospital
state: Ohio
city: Westerville
country: United States
facility: Mount Carmel St. Ann's Hospital
state: Ohio
city: Zanesville
country: United States
facility: Genesis Cancer Care Center (Genesis Healthcare System)
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Heather Hampel, MS, LGC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hampel H, Frankel WL, Martin E, Arnold M, Khanduja K, Kuebler P, Nakagawa H, Sotamaa K, Prior TW, Westman J, Panescu J, Fix D, Lockman J, Comeras I, de la Chapelle A. Screening for the Lynch syndrome (hereditary nonpolyposis colorectal cancer). N Engl J Med. 2005 May 5;352(18):1851-60. doi: 10.1056/NEJMoa043146.
citation: Hampel H, Frankel WL, Martin E, Arnold M, Khanduja K, Kuebler P, Clendenning M, Sotamaa K, Prior T, Westman JA, Panescu J, Fix D, Lockman J, LaJeunesse J, Comeras I, de la Chapelle A. Feasibility of screening for Lynch syndrome among patients with colorectal cancer. J Clin Oncol. 2008 Dec 10;26(35):5783-8. doi: 10.1200/JCO.2008.17.5950. Epub 2008 Sep 22.
citation: Palomaki GE, McClain MR, Melillo S, Hampel HL, Thibodeau SN. EGAPP supplementary evidence review: DNA testing strategies aimed at reducing morbidity and mortality from Lynch syndrome. Genet Med. 2009 Jan;11(1):42-65. doi: 10.1097/GIM.0b013e31818fa2db. No abstract available.
citation: Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group. Recommendations from the EGAPP Working Group: genetic testing strategies in newly diagnosed individuals with colorectal cancer aimed at reducing morbidity and mortality from Lynch syndrome in relatives. Genet Med. 2009 Jan;11(1):35-41. doi: 10.1097/GIM.0b013e31818fa2ff.