Trial record 2 of 167 for:    fecal | Recruiting | Exclude Unknown | United States

Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing (ASC-FIT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Forsyth Medical Center
Sponsor:
Information provided by (Responsible Party):
Forsyth Medical Center
ClinicalTrials.gov Identifier:
NCT00892593
First received: May 1, 2009
Last updated: July 18, 2014
Last verified: July 2014
  Purpose

The study will determine if adding fecal immunochemical testing (FIT) at yearly intervals to a colonoscopy screening program will improve colon cancer detection rates.


Condition Intervention
Colon Cancer
Device: Fecal Immunochemical Testing

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing

Resource links provided by NLM:


Further study details as provided by Forsyth Medical Center:

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. [ Time Frame: yearly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the pathology found at repeat colonoscopy in each group. [ Time Frame: Yearly ] [ Designated as safety issue: No ]

Estimated Enrollment: 4100
Study Start Date: May 2009
Estimated Study Completion Date: May 2020
Estimated Primary Completion Date: May 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Fecal Immunochemical Testing-Surveillance
Fecal Immunochemical Testing performed at yearly intervals.
Device: Fecal Immunochemical Testing
Fecal Immunochemical Testing is a stool test specific for human hemoglobin.
Other Name: FIT
No Intervention: 2 Usual Care - Surveillance
No Intervention: 3 Usual Care - Screening
Experimental: 4 Fecal Immunochemical Testing-Screening
Fecal Immunochemical Testing yearly, beginning at year 6.
Device: Fecal Immunochemical Testing
Fecal Immunochemical Testing is a stool test specific for human hemoglobin.
Other Name: FIT

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00892593

Contacts
Contact: Debra W Norwood 336-718-6045 dwnorwood@novanthealth.org
Contact: Wendy L Hobbs 336-718-5808 wlhobbs@novanthealth.org

Locations
United States, North Carolina
Piedmont Gastroenterology Specialists, PA Recruiting
Winston Salem, North Carolina, United States, 27103
Contact: Erica Habersham    336-277-0203    ehabersham@novanthealth.org   
Contact: Kyeshia Robinson    336.718-5813    kyeshia.robinson@novanthealth.org   
Principal Investigator: Daniel Murphy, MD         
Salem Gastroenterology Associates, PA Recruiting
Winston Salem, North Carolina, United States, 27103
Contact: Erica Habersham    336-277-0203    ehabersham@novanthealth.org   
Digestive Health Specialists, PA Active, not recruiting
Winston Salem, North Carolina, United States, 27103
Sponsors and Collaborators
Forsyth Medical Center
Investigators
Principal Investigator: Daniel Murphy, M.D. Piedmont Gastroenterology Specialists
  More Information

Additional Information:
No publications provided

Responsible Party: Forsyth Medical Center
ClinicalTrials.gov Identifier: NCT00892593     History of Changes
Other Study ID Numbers: ASC-FIT
Study First Received: May 1, 2009
Last Updated: July 18, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Forsyth Medical Center:
colon
neoplasia
polyp
adenoma
FIT
cancer

ClinicalTrials.gov processed this record on October 01, 2014