Recruiting

FIT with Colonoscopy

Sponsor:

Forsyth Medical Center

Code:

NCT00892593

Conditions

Colon Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Fecal Immunochemical Testing

Fecal Immunochemical Testing

Study Details

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.

Conditions

Colon Cancer

Study ID

NCT00892593

Start date

May, 2009

Status verified date

Jul, 2014

Completion date

May, 2020

Anticipated

Primary completion date

May, 2019

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

4100 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

experimental: 1 Fecal Immunochemical Testing-Surveillance

Fecal Immunochemical Testing performed at yearly intervals.

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.

Interventions

Fecal Immunochemical Testing

Fecal Immunochemical Testing is a stool test specific for human hemoglobin.

Fecal Immunochemical Testing

Fecal Immunochemical Testing is a stool test specific for human hemoglobin.

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Debra W Norwood

336-718-6045dwnorwood@novanthealth.org

Wendy L Hobbs

336-718-5808wlhobbs@novanthealth.org

Locations

Piedmont Gastroenterology Specialists, PA

Recruiting

Winston Salem, North Carolina, United States, 27103

Contacts

Erica Habersham

336-277-0203ehabersham@novanthealth.org

Kyeshia Robinson

336.718-5813kyeshia.robinson@novanthealth.org

Principal Investigator:

Daniel Murphy, MD

Salem Gastroenterology Associates, PA

Recruiting

Winston Salem, North Carolina, United States, 27103

Contacts

Erica Habersham

336-277-0203ehabersham@novanthealth.org

More Information

Sponsor

Forsyth Medical Center

Last update posted

Jul 21, 2014

Last verified

Jul, 2014

Keywords

  • colon
  • neoplasia
  • polyp
  • adenoma
  • FIT
  • cancer

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Forsyth Medical Center on 2014-07-21.