Status:
COMPLETED
Ohio Colorectal Cancer Prevention Initiative
Lead Sponsor:
Ohio State University Comprehensive Cancer Center
Conditions:
Lynch Syndrome
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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-ris...
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% ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 26 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 2 2018
Estimated Enrollment :
3470 Patients enrolled
Trial Details
Trial ID
NCT01850654
Start Date
December 26 2012
End Date
January 2 2018
Last Update
June 28 2018
Active Locations (49)
Enter a location and click search to find clinical trials sorted by distance.
1
Akron General Medical Center
Akron, Ohio, United States, 44109
2
Akron City/St. Thomas Hospital (Summa Health System)
Akron, Ohio, United States, 44309
3
Summa Barberton (Summa Health System)
Barberton, Ohio, United States, 44203
4
Mercy Clermont
Batavia, Ohio, United States