Colon CancerASC-FITNCT00892593
Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing
A study testing Fecal Immunochemical Testing in people with Colon Cancer, run by Forsyth Medical Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colon Cancer
- What is being tested?
- Fecal Immunochemical Testing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,100 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2009to May 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
3 sites in 1 country.
United States3 sites, 2 recruiting
- Active, not recruiting
Digestive Health Specialists, PA
Winston-Salem, North Carolina, 27103
- Recruiting
Piedmont Gastroenterology Specialists, PA
Winston-Salem, North Carolina, 27103
Erica Habersham, 336-277-0203, ehabersham@novanthealth.org
Kyeshia Robinson, 336.718-5813, kyeshia.robinson@novanthealth.org
- Recruiting
Salem Gastroenterology Associates, PA
Winston-Salem, North Carolina, 27103
Erica Habersham, 336-277-0203, ehabersham@novanthealth.org
About this study
The study will determine if adding fecal immunochemical testing (FIT) at yearly intervals to a colonoscopy screening program will improve colon cancer detection rates.
Read the 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
- Conditions
- Colon Cancer
- Being tested
- Fecal Immunochemical Testing
- Keywords
- colon, neoplasia, polyp, adenoma, FIT, cancer
- Medical subject headings
- Colonic Neoplasms, Neoplasms, Polyps, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal Immunochemical TestingDevice
Also called FIT
Fecal Immunochemical Testing is a stool test specific for human hemoglobin.
Fecal Immunochemical TestingDevice
Also called FIT
Fecal Immunochemical Testing is a stool test specific for human hemoglobin.
| Study group | Role | What they receive |
|---|---|---|
| 1 Fecal Immunochemical Testing-Surveillance | Experimental | Fecal Immunochemical Testing performed at yearly intervals. Receives: Device: Fecal Immunochemical Testing |
| 2 Usual Care - Surveillance | No intervention | Not described |
| 3 Usual Care - Screening | No intervention | Not described |
| 4 Fecal Immunochemical Testing-Screening | Experimental | Fecal Immunochemical Testing yearly, beginning at year 6. Receives: Device: Fecal Immunochemical Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: yearly
Secondary outcomes (1)
the pathology found at repeat colonoscopy in each group.
Measured: Yearly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2009 (estimated)
- Study startMay 2009
- Primary completionMay 2019 (estimated)
- Study completionMay 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Forsyth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel Murphy, M.D., Principal investigator, Piedmont Gastroenterology Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00892593
- Sponsor's protocol ID
- ASC-FIT
- Acronym
- ASC-FIT
- Status last verified
- Jul 2014
- First submitted
- 1 May 2009
- Last updated
- 21 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmentation of Screening Colonoscopy With Fecal Immunochemical Testing
- ClinicalTrials.gov ID
- NCT00892593
- Acronym / sponsor ID
- ASC-FIT / ASC-FIT
- Conditions
- Colon Cancer
- Keywords
- colon, neoplasia, polyp, adenoma, FIT, cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,100 participants (estimated)
- Lead sponsor
- Forsyth Medical CenterUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- May 2019 (estimated)
- Study completion
- May 2020 (estimated)
- First posted
- 4 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 Fecal Immunochemical Testing-Surveillance | Experimental | Device: Fecal Immunochemical TestingFecal Immunochemical Testing performed at yearly intervals. |
| 2 Usual Care - Surveillance | No intervention | – |
| 3 Usual Care - Screening | No intervention | – |
| 4 Fecal Immunochemical Testing-Screening | Experimental | Device: Fecal Immunochemical TestingFecal Immunochemical Testing yearly, beginning at year 6. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fecal Immunochemical TestingAlso: FITFecal Immunochemical Testing is a stool test specific for human hemoglobin. | Device | 1 Fecal Immunochemical Testing-Surveillance |
| Fecal Immunochemical TestingAlso: FITFecal Immunochemical Testing is a stool test specific for human hemoglobin. | Device | 4 Fecal Immunochemical Testing-Screening |
Primary outcome
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
1 secondary outcome
the pathology found at repeat colonoscopy in each group.
Time frame: Yearly
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2014.
- NovantHealthClinicalResearch/ASC-FITLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Murphy, M.D. principal investigator
Piedmont Gastroenterology Specialists
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fecal Immunochemical Testing in people with Colon Cancer, run by Forsyth Medical Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Debra W Norwood (336-718-6045, dwnorwood@novanthealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2014.