Back to resultsAugmentation of Screening Colonoscopy With Fecal Immunochemical Testing (ASC-FIT)
Primary Purpose
Colon Cancer
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Fecal Immunochemical Testing
Fecal Immunochemical Testing
Sponsored by
About this trial
This is an interventional screening trial for Colon Cancer focused on measuring colon, neoplasia, polyp, adenoma, FIT, cancer
Eligibility Criteria
Inclusion Criteria:
Group I (positive colonoscopy)
- 18 to 75 years of age
- male or female
- willing to provide written informed consent
- In the event that the colonoscopy is incomplete, or polypectomy is partial, the above patients are eligible if a successful examination is completed within 6 months of the inadequate exam.
Group II (negative colonoscopy)
- 50 to 69 years of age
- Male or female
- Willing to provide written informed consent
- In the event that the colonoscopy is incomplete, the patient is eligible if a successful examination is completed within 6 months of the inadequate exam.
Exclusion Criteria:
Group I (positive colonoscopy)
- chronic use of coumadin
- history of previous GI malignancy, inflammatory bowel disease (Crohns disease, ulcerative colitis)
- age or health status contraindicates repeat colonoscopy
- history of Familial Polyposis or Hereditary Nonpolyposis Colon Cancer Syndrome
- The index colonoscopy resulted in a perforation requiring surgical repair
- An otherwise qualifying colonoscopy is followed by a recommendation for repeat colonoscopy in ≤ 1 yr.
Group II (negative colonoscopy)
- chronic use of coumadin
- history of previous GI malignancy, inflammatory bowel disease (Crohns disease, ulcerative colitis)
- age or health status contraindicates repeat colonoscopy
- history of Familial Polyposis or Hereditary Nonpolyposis Colon Cancer Syndrome
- The index colonoscopy resulted in a perforation requiring surgical repair
- Significant family history resulting in a recommendation for repeat colonoscopy in 5 years or less
Sites / Locations
- Digestive Health Specialists, PA
- Piedmont Gastroenterology Specialists, PARecruiting
- Salem Gastroenterology Associates, PARecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
No Intervention
No Intervention
Experimental
Arm Label
1 Fecal Immunochemical Testing-Surveillance
2 Usual Care - Surveillance
3 Usual Care - Screening
4 Fecal Immunochemical Testing-Screening
Arm Description
Fecal Immunochemical Testing performed at yearly intervals.
Fecal Immunochemical Testing yearly, beginning at year 6.
Outcomes
Primary Outcome Measures
rate of significant colon neoplasia among those who enter a screening or surveillance program with FIT testing added at yearly intervals vs. that of "usual care" patients in the same patient population.
Secondary Outcome Measures
the pathology found at repeat colonoscopy in each group.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00892593
Brief Title
Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing
Acronym
ASC-FIT
Official Title
Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing
Study Type
Interventional
2. Study Status
Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2009 (undefined)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forsyth Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study will determine if adding fecal immunochemical testing (FIT) at yearly intervals to a colonoscopy screening program will improve colon cancer detection rates.
Detailed Description
This study will evaluate the benefit of augmenting a compliant College of Gastroenterology colorectal cancer screening program with the addition of yearly FIT testing at two critical points in the current recommended follow up: 1. In patients found to have adenomatous polyps for the first time after colonoscopy, the addition of FIT in yearly intervals following index colonoscopy and 2. For subjects with "clean" colonoscopies (no polyps found), the addition of FIT at yearly intervals starting in year 6 and continuing to year 10 or subsequent colonoscopy. Current screening guidelines do not recommend the combination of colonoscopy and FOBT.
Two factors plague an effective colon cancer screening program: 1) a less than 100% sensitivity (95% ) for optical colonoscopy to detect colon cancer, and 2) Limitations of guaiac based stool testing: low sensitivity ( 5% in single use) for detection of colon cancer and the traditional gFOBT is cumbersome for patients to perform, impeding patient acceptance and adherence.
FIT offers a FOBT with improved sensitivity (65% for invasive colon cancer) and improved specificity and better patient compliance. The addition of FIT after initial colonoscopy could be applied to a screening program and thereby salvage "missed" lesions by increased detection rates
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
colon, neoplasia, polyp, adenoma, FIT, cancer
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
4100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1 Fecal Immunochemical Testing-Surveillance
Arm Type
Experimental
Arm Description
Fecal Immunochemical Testing performed at yearly intervals.
Arm Title
2 Usual Care - Surveillance
Arm Type
No Intervention
Arm Title
3 Usual Care - Screening
Arm Type
No Intervention
Arm Title
4 Fecal Immunochemical Testing-Screening
Arm Type
Experimental
Arm Description
Fecal Immunochemical Testing yearly, beginning at year 6.
Intervention Type
Device
Intervention Name(s)
Fecal Immunochemical Testing
Other Intervention Name(s)
FIT
Intervention Description
Fecal Immunochemical Testing is a stool test specific for human hemoglobin.
Intervention Type
Device
Intervention Name(s)
Fecal Immunochemical Testing
Other Intervention Name(s)
FIT
Intervention Description
Fecal Immunochemical Testing is a stool test specific for human hemoglobin.
Primary Outcome Measure Information:
Title
rate of significant colon neoplasia among those who enter a screening or surveillance program with FIT testing added at yearly intervals vs. that of "usual care" patients in the same patient population.
Time Frame
yearly
Secondary Outcome Measure Information:
Title
the pathology found at repeat colonoscopy in each group.
Time Frame
Yearly
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Group I (positive colonoscopy)
18 to 75 years of age
male or female
willing to provide written informed consent
In the event that the colonoscopy is incomplete, or polypectomy is partial, the above patients are eligible if a successful examination is completed within 6 months of the inadequate exam.
Group II (negative colonoscopy)
50 to 69 years of age
Male or female
Willing to provide written informed consent
In the event that the colonoscopy is incomplete, the patient is eligible if a successful examination is completed within 6 months of the inadequate exam.
Exclusion Criteria:
Group I (positive colonoscopy)
chronic use of coumadin
history of previous GI malignancy, inflammatory bowel disease (Crohns disease, ulcerative colitis)
age or health status contraindicates repeat colonoscopy
history of Familial Polyposis or Hereditary Nonpolyposis Colon Cancer Syndrome
The index colonoscopy resulted in a perforation requiring surgical repair
An otherwise qualifying colonoscopy is followed by a recommendation for repeat colonoscopy in ≤ 1 yr.
Group II (negative colonoscopy)
chronic use of coumadin
history of previous GI malignancy, inflammatory bowel disease (Crohns disease, ulcerative colitis)
age or health status contraindicates repeat colonoscopy
history of Familial Polyposis or Hereditary Nonpolyposis Colon Cancer Syndrome
The index colonoscopy resulted in a perforation requiring surgical repair
Significant family history resulting in a recommendation for repeat colonoscopy in 5 years or less
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Debra W Norwood
Phone
336-718-6045
Email
dwnorwood@novanthealth.org
First Name & Middle Initial & Last Name or Official Title & Degree
Wendy L Hobbs
Phone
336-718-5808
Email
wlhobbs@novanthealth.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Murphy, M.D.
Organizational Affiliation
Piedmont Gastroenterology Specialists
Official's Role
Principal Investigator
Facility Information:
Facility Name
Digestive Health Specialists, PA
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Piedmont Gastroenterology Specialists, PA
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Habersham
Phone
336-277-0203
Email
ehabersham@novanthealth.org
First Name & Middle Initial & Last Name & Degree
Kyeshia Robinson
Phone
336.718-5813
Email
kyeshia.robinson@novanthealth.org
First Name & Middle Initial & Last Name & Degree
Daniel Murphy, MD
Facility Name
Salem Gastroenterology Associates, PA
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erica Habersham
Phone
336-277-0203
Email
ehabersham@novanthealth.org
12. IPD Sharing Statement
Links:
URL
http://www.novanthealth.org/forsyth-medical-center/services/clinical-research.aspx
Description
NovantHealthClinicalResearch/ASC-FIT
Learn more about this trial
Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing
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