Ohio Colorectal Cancer Prevention Initiative
OCCPI
1 other identifier
interventional
3,470
1 country
49
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2012
Longer than P75 for not_applicable
49 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 26, 2012
CompletedFirst Submitted
Initial submission to the registry
May 3, 2013
CompletedFirst Posted
Study publicly available on registry
May 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2018
CompletedJune 28, 2018
June 1, 2018
5 years
May 3, 2013
June 26, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Determine the Incidence of Hereditary Cancer Syndromes among Newly Diagnosed Colorectal Cancer Patients
Through tumor testing for Lynch syndrome and follow-up genetic testing for all patients with abnormal tumor testing and select patients with normal tumor testing (those diagnosed under age 50 and those at or over age 50 with a first degree relative with colorectal or endometrial cancer or synchronous or metachronous colon or endometrial cancer).
36 months (initial assessment)
Study Arms (3)
Probands
OTHERParticipants with colorectal or endometrial cancer.
First-degree relatives of the participants with CRC
OTHERThe first-degree relatives of the CRC probands (participants with colorectal cancer).
At-risk relatives
OTHERThe relatives of the participants found to have Lynch syndrome.
Interventions
All participants with CRC or EC will have LS tumor screening (MSI, IHC, methylation if applicable).
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.
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
- Newly diagnosed with endometrial cancer (any histology except sarcoma) and have a resection between 1/1/2013 and 12/31/2016 at OSU only.
- All at-risk relatives of the participants found to have LS.
- First-degree relatives (parents, siblings and adult children ≥ 25 years of age) of the CRC participants who do not have LS.
You may not qualify if:
- Prisoners.
- Individuals who are under the age of 18.
- Individuals must have a primary colorectal or endometrial cancer, not a recurrence of a previous colorectal or endometrial cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (49)
Akron General Medical Center
Akron, Ohio, 44109, United States
Akron City/St. Thomas Hospital (Summa Health System)
Akron, Ohio, 44309, United States
Summa Barberton (Summa Health System)
Barberton, Ohio, 44203, United States
Mercy Clermont
Batavia, Ohio, United States
Mercy Medical Center
Canton, Ohio, 44708, United States
Aultman Hospital
Canton, Ohio, 44710, United States
Adena Health System
Chillicothe, Ohio, 45601, United States
The Christ Hospital
Cincinnati, Ohio, 45219, United States
Good Samaritan Hospital (TriHealth)
Cincinnati, Ohio, 45220, United States
Bethesda North Hospital (TriHealth)
Cincinnati, Ohio, 45242, United States
Mercy Anderson
Cincinnati, Ohio, United States
Mercy West
Cincinnati, Ohio, United States
The Jewish Hospital
Cincinnati, Ohio, United States
MetroHealth
Cleveland, Ohio, 44109, United States
Fairview Hospital
Cleveland, Ohio, 44111, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Mount Carmel East Hospital
Columbus, Ohio, 43213, United States
Riverside Methodist Hospital
Columbus, Ohio, 43214, United States
Grant Medical Center
Columbus, Ohio, 43215, United States
Mount Carmel West Hospital
Columbus, Ohio, 43222, United States
Doctors Hospital
Columbus, Ohio, 43228, United States
Summa Western Reserve (Summa Health System)
Cuyahoga Falls, Ohio, 44223, United States
Miami Valley Hospital
Dayton, Ohio, 45409, United States
Good Samaritan Hospital Dayton
Dayton, Ohio, 45415, United States
Kettering Medical Center
Dayton, Ohio, 45429, United States
Wright-Patterson Medical Center
Dayton, Ohio, 45433, United States
Grady Memorial Hospital
Delaware, Ohio, 43015, United States
Mercy Fairfield
Fairfield, Ohio, United States
Blanchard Valley Health System
Findlay, Ohio, 45840, United States
Wayne Healthcare
Greenville, Ohio, 45331, United States
Fairfield Medical Center
Lancaster, Ohio, 43130, United States
St. Rita's Medical Center
Lima, Ohio, 45801, United States
Marietta Memorial Hospital
Marietta, Ohio, 45750, United States
Marion General Hospital
Marion, Ohio, United States
St. Luke's Hospital (ProMedica)
Maumee, Ohio, 43537, United States
Toledo Clinic Cancer Center
Maumee, Ohio, United States
Hillcrest Hospital
Mayfield Heights, Ohio, 44124, United States
Atrium Medical Center
Middletown, Ohio, 45005, United States
Knox Community Hospital
Mount Vernon, Ohio, 43050, United States
Licking Memorial Hospital
Newark, Ohio, 43055, United States
Southern Ohio Medical Center
Portsmouth, Ohio, 45648, United States
Robinson Memorial (Summa Health System)
Ravenna, Ohio, 44266, United States
Springfield Regional Medical Center
Springfield, Ohio, 45504, United States
Flower Hospital (ProMedica Health System)
Sylvania, Ohio, 43560, United States
Toledo Hospital (Promedica Health System)
Toledo, Ohio, 43606, United States
Upper Valley Medical Center
Troy, Ohio, 45373, United States
South Pointe Hospital
Warrensville Heights, Ohio, United States
Mount Carmel St. Ann's Hospital
Westerville, Ohio, 43081, United States
Genesis Cancer Care Center (Genesis Healthcare System)
Zanesville, Ohio, 43701, United States
Related Publications (4)
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.
PMID: 15872200BACKGROUNDHampel 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.
PMID: 18809606BACKGROUNDPalomaki 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.
PMID: 19125127BACKGROUNDEvaluation 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.
PMID: 19125126BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Heather Hampel, MS, LGC
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
May 3, 2013
First Posted
May 9, 2013
Study Start
December 26, 2012
Primary Completion
January 2, 2018
Study Completion
January 2, 2018
Last Updated
June 28, 2018
Record last verified: 2018-06