Brief Summary
The study aims to show non-inferiority in the clinical performance of the investigational assay, Epi proColon, to FIT using matched blood and stool specimens from screening-guideline eligible subjects.
Brief Title
Head to Head Study Epi proColon and FIT
Detailed Description
There is strong evidence supporting the use of FOBT in CRC screening, with the earliest randomized controlled trials demonstrating a reduction in CRC incidence and mortality from CRC screening. Despite the implementation and incremental improvements in gFOBT- and FIT-based tests, they continue to represent a small percentage of CRC screening and currently remain largely the province of large, integrated healthcare delivery systems. Reasons for the limited adoption of stool-based testing are complicated, but include lack of physician recommendation, patient preferences, and cultural barriers.
Availability of a blood-based test may overcome the adoption challenges presently facing stool-based CRC screening and facilitate better compliance with CRC screening guidelines. However, there are currently no FDA-approved in vitro diagnostic tests for detection of CRC in a blood sample. As such, a high through-put blood-based test with performance characteristics similar to fecal testing could satisfy this clinical need.
This study is designed to prospectively collect matched blood and stool specimens and clinical data from screening guideline-eligible subjects found to have invasive colorectal cancer (CRC) at colonoscopy, i.e. AJCC/UICC stages I, II, III, and IV, with collection of specimens and testing after colonoscopy and from screening guideline-eligible subjects with blood and stool specimens collected before colonoscopy. A completed subject will have a FIT result, an Epi proColon result, and a medical diagnosis/colonoscopy determined clinical status (CRC, non-CRC). Demographic and baseline covariates will be reported for each individual.
Availability of a blood-based test may overcome the adoption challenges presently facing stool-based CRC screening and facilitate better compliance with CRC screening guidelines. However, there are currently no FDA-approved in vitro diagnostic tests for detection of CRC in a blood sample. As such, a high through-put blood-based test with performance characteristics similar to fecal testing could satisfy this clinical need.
This study is designed to prospectively collect matched blood and stool specimens and clinical data from screening guideline-eligible subjects found to have invasive colorectal cancer (CRC) at colonoscopy, i.e. AJCC/UICC stages I, II, III, and IV, with collection of specimens and testing after colonoscopy and from screening guideline-eligible subjects with blood and stool specimens collected before colonoscopy. A completed subject will have a FIT result, an Epi proColon result, and a medical diagnosis/colonoscopy determined clinical status (CRC, non-CRC). Demographic and baseline covariates will be reported for each individual.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Colorectal Cancer
Eligibility Criteria
Inclusion Criteria:
Group A
* Willing and able to sign an informed consent and adhere to study requirements
* 50 - 84 years of age at blood and stool sampling
* Colonoscopic diagnosis of colorectal carcinoma
* Colonoscopy within 6 months before inclusion into study
* Blood and stool sampling a minimum of 10 days after colonoscopy and before resection surgery
Group B
* Willing and able to sign an informed consent and adhere to study requirements
* 50 - 84 years of age at blood and stool sampling
* Able to provide blood and stool sample prior to bowel prep and colonoscopy
Exclusion Criteria:
Group A
* Subject with curative biopsy during colonoscopy
Group A and B
* Previous personal history of CRC or previous colonocopy resulting in a recommendation to repeat colonoscopy at an interval less than 10 years
* Neoadjuvant treatment
* Familial risk for colorectal cancer
* History of inflammatory bowel disease
* Acute or chronic gastritis
* Current diagnosis of any other cancer
* Overt rectal bleeding or bleeding hemorrhoids
* Known infection with HIV, HBV, or HCV
* Subject concurrently receiving intravenous fluid at the time of the sample collection
Group A
* Willing and able to sign an informed consent and adhere to study requirements
* 50 - 84 years of age at blood and stool sampling
* Colonoscopic diagnosis of colorectal carcinoma
* Colonoscopy within 6 months before inclusion into study
* Blood and stool sampling a minimum of 10 days after colonoscopy and before resection surgery
Group B
* Willing and able to sign an informed consent and adhere to study requirements
* 50 - 84 years of age at blood and stool sampling
* Able to provide blood and stool sample prior to bowel prep and colonoscopy
Exclusion Criteria:
Group A
* Subject with curative biopsy during colonoscopy
Group A and B
* Previous personal history of CRC or previous colonocopy resulting in a recommendation to repeat colonoscopy at an interval less than 10 years
* Neoadjuvant treatment
* Familial risk for colorectal cancer
* History of inflammatory bowel disease
* Acute or chronic gastritis
* Current diagnosis of any other cancer
* Overt rectal bleeding or bleeding hemorrhoids
* Known infection with HIV, HBV, or HCV
* Subject concurrently receiving intravenous fluid at the time of the sample collection
Inclusion Criteria
Inclusion Criteria:
Group A
* Willing and able to sign an informed consent and adhere to study requirements
* 50 - 84 years of age at blood and stool sampling
* Colonoscopic diagnosis of colorectal carcinoma
* Colonoscopy within 6 months before inclusion into study
* Blood and stool sampling a minimum of 10 days after colonoscopy and before resection surgery
Group B
* Willing and able to sign an informed consent and adhere to study requirements
* 50 - 84 years of age at blood and stool sampling
* Able to provide blood and stool sample prior to bowel prep and colonoscopy
Group A
* Willing and able to sign an informed consent and adhere to study requirements
* 50 - 84 years of age at blood and stool sampling
* Colonoscopic diagnosis of colorectal carcinoma
* Colonoscopy within 6 months before inclusion into study
* Blood and stool sampling a minimum of 10 days after colonoscopy and before resection surgery
Group B
* Willing and able to sign an informed consent and adhere to study requirements
* 50 - 84 years of age at blood and stool sampling
* Able to provide blood and stool sample prior to bowel prep and colonoscopy
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
84 Years
Minimum Age
50 Years
NCT Id
NCT01580540
Org Class
Industry
Org Full Name
Epigenomics, Inc
Org Study Id
Epigenomics-SPR 0022
Overall Status
Completed
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
Comparison of the Performance of the Epi proColon and Fecal ImmunochemicalTest Post Colonoscopy in Subjects With Colorectal Cancer and Pre Colonoscopy in Subjects From a Guideline-Eligible Screening Population
Primary Outcomes
Outcome Measure
Non-inferiority of Epi proColon test result compared to FIT result using a 95% confidence interval for difference in sensitivities and differences in specificities below a strictly defined margin.
Outcome Time Frame
At completion of testing.
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Study Population
Subjects are recruited from gastroenterology clinics and surgical centers in the United States.
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
84
Minimum Age Number (converted to Years and rounded down)
50
Investigators
Investigator Type
Principal Investigator
Investigator Name
Rebecca Levine
Investigator Email
relevine@montefiore.org
Investigator Phone
718-405-8236