NCT00892593

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,100

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2009

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2009

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

July 21, 2014

Status Verified

July 1, 2014

Enrollment Period

10 years

First QC Date

May 1, 2009

Last Update Submit

July 18, 2014

Conditions

Colon Cancer

Keywords

colonneoplasiapolypadenomaFITcancer

Outcome Measures

Primary Outcomes (1)

  • 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.

    yearly

Secondary Outcomes (1)

  • the pathology found at repeat colonoscopy in each group.

    Yearly

Study Arms (4)

1 Fecal Immunochemical Testing-Surveillance

EXPERIMENTAL

Fecal Immunochemical Testing performed at yearly intervals.

Device: Fecal Immunochemical Testing

2 Usual Care - Surveillance

NO INTERVENTION

3 Usual Care - Screening

NO INTERVENTION

4 Fecal Immunochemical Testing-Screening

EXPERIMENTAL

Fecal Immunochemical Testing yearly, beginning at year 6.

Device: Fecal Immunochemical Testing

Interventions

Fecal Immunochemical TestingDEVICE

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

Also known as: FIT
1 Fecal Immunochemical Testing-Surveillance

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Group I (positive colonoscopy)
  • 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)
  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Digestive Health Specialists, PA

Winston-Salem, North Carolina, 27103, United States

ACTIVE NOT RECRUITING

Piedmont Gastroenterology Specialists, PA

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Salem Gastroenterology Associates, PA

Winston-Salem, North Carolina, 27103, United States

RECRUITING

Related Links

MeSH Terms

Conditions

Colonic NeoplasmsNeoplasmsPolypsAdenoma

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Daniel Murphy, M.D.

    Piedmont Gastroenterology Specialists

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Debra W Norwood

CONTACT

336-718-6045dwnorwood@novanthealth.org

Wendy L Hobbs

CONTACT

336-718-5808wlhobbs@novanthealth.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2009

First Posted

May 4, 2009

Study Start

May 1, 2009

Primary Completion

May 1, 2019

Study Completion

May 1, 2020

Last Updated

July 21, 2014

Record last verified: 2014-07

Locations

US(3)