Colorectal CancerBestFITNCT03264898
Comparative Effectiveness of FITs With Colonoscopy
An observational study of Colorectal Cancer, run by Barcey T. Levy at 3 sites in United States.
Trial summary
Colorectal cancer is a preventable and/or a treatable cancer, but at least 43% of the United States population is not up-to-date with screening. Although 90% of colorectal cancer screening is done using colonoscopy, most other countries use fecal immunochemical tests, reserving colonoscopy for those with a positive… Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Fecal immunochemical test (FIT)
- Type of treatment
- Medical device
- How many people
- 3,761 participants
- Where
- 3 sitesUnited States
- Study dates
- 2 Oct 2017to 1 Oct 2023
- Phase
- Observational
- 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 50 to 85 years
- All sexes
- Adult, Older adult
Study population: Patients being scheduled for screening or surveillance colonoscopies meeting the study criteria at three academic health centers
Who may be able to join
- scheduled for a screening or surveillance colonoscopy
Who cannot join
- familial polyposis syndromes: ulcerative colitis or Crohn's disease: or active rectal bleeding
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of North Carolina
Chapel Hill, North Carolina, 27599
Texas Tech University Health Sciences Center
El Paso, Texas, 79924
University of Iowa
Iowa City, Iowa, 52242
About this study
Official title: Comparative Effectiveness of Fecal Immunochemical Tests With Optical Colonoscopy (R01 CA215034)
Colorectal cancer is a preventable and/or a treatable cancer, but at least 43% of the United States population is not up-to-date with screening. Although 90% of colorectal cancer screening is done using colonoscopy, most other countries use fecal immunochemical tests, reserving colonoscopy for those with a positive fecal immunochemical test. This project will provide the foundation for a paradigm shift for colorectal cancer screening in the United States by identifying how well 5 different FITs work for detecting screening relevant neoplasia, thus reducing morbidity and mortality for colorectal cancer.
Read the detailed description
Colorectal cancer (CRC) is the third most common cancer and the third leading cause of cancer death in both men and women in the U.S., with nearly 50,000 deaths each year. Since CRC develops over a number of years from precursor lesions called polyps, it is largely detectable and preventable in early stages. As these polyps become larger, they, like most CRCs, tend to bleed, which is the rationale for the use of fecal occult blood tests (FOBTs) to detect both polyps and cancers early, while they are curable. However, early screening and detection is much less common than it could be, with about 43% of eligible individuals unscreened. Fecal immunochemical tests (FITs) are a type of FOBT that can be a sensitive, specific, and low cost alternative to colonoscopy for CRC screening. Modeling studies have shown that for population screening, a strategy of annual FIT testing from age of 50 to 75 years results in an equal number of life-years gained as compared with colonoscopy every 10 years. However, about 90% of screening in the U.S. is done with colonoscopy, the most expensive and invasive screening test. FITs are far less costly and largely replacing the guaiac test in CRC screening programs internationally, where only individuals with positive results are referred for a colonoscopy. Studies done on FITs in other countries often used FITs not available in the U.S. or studied high-risk populations; thus, results are not applicable in the U.S. It is critical to determine the FIT(s) with the best test characteristics in order to implement successful FIT-based screening programs in this country.
It is estimated that 24 million more individuals will need to be screened by 2018 to reach the "80% by 2018" goal set by the National Colorectal Cancer Roundtable. To address this knowledge gap, investigators propose to compare the test characteristics of three Clinical Laboratory Improvement Amendments (CLIA)-waived FITs and two automated FITs, using colonoscopy as the gold standard. The rationale for this proposed study is that, for almost all of the FITs currently marketed in the U.S., there is no evidence of the accuracy claimed. Specific aims are: Aim 1: To assess the diagnostic accuracy for advanced colorectal neoplasms of three of the most commonly used CLIA-waived FITs and two automated FITs, using colonoscopy as the gold standard.
Aim 2: To evaluate the diagnostic accuracy of two quantitative FITs using receiver operating characteristic (ROC) analysis. Aim 3: To assess factors associated with false positive and false negative FIT results for each device.
These findings will provide essential information about FITs with the best test characteristics for future expanded use of FIT, critically important to achieving the long-term goal of reducing morbidity and mortality from CRC. FITs are more acceptable to patients, will allow higher screening rates, and will reduce costs as compared with a screening strategy based on colonoscopy as the primary initial screening method.
- Conditions
- Colorectal Cancer
- Being tested
- Fecal immunochemical test (FIT)
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fecal immunochemical test (FIT)Device
FIT is a type of fecal occult blood test that uses antibodies to hemoglobin to detect blood in stool.
| Study group | Role | What they receive |
|---|---|---|
| Fecal Immunochemical Test (FIT) Group | Each participant will complete 5 different FITs, on a single stool sample collected in a hat. Each participant will undergo optical colonoscopy and their FIT results compared with their colonoscopy with biopsy results (if applicable). We will calculate the test characteristics of each FIT. Receives: Device: Fecal immunochemical test (FIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Advanced adenoma or cancer as assessed by colonoscopy with biopsy if needed
Individual FIT brand results of negative, positive, or invalid
Measured: About 21 days from collection of FIT to performance of colonoscopy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2017
- Study start2 Oct 2017
- Primary completion7 Mar 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Colorectal 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 3,761 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barcey T. Levy
- Sponsor type
- University, hospital or other
- Collaborators
- University of North Carolina, Texas Tech University Health Sciences Center
- Responsible party
- Sponsor-investigator, Barcey T. Levy, University of Iowa
- Investigators
- Barcey T Levy, PhD, MD, Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03264898
- Sponsor's protocol ID
- IRB ID#201610814
- Acronym
- BestFIT
- Status last verified
- Jul 2024
- First submitted
- 21 Aug 2017
- Last updated
- 2 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the key publications are accepted and finalized, de-identified data and the codebook will be made available to anyone with a legitimate request who follows the Data Sharing agreement.
Publications
Smith RA, Andrews K, Brooks D, DeSantis CE, Fedewa SA, Lortet-Tieulent J, Manassaram-Baptiste D, Brawley OW, Wender RC. Cancer screening in the United States, 2016: A review of current American Cancer Society guidelines and current issues in cancer screening. CA Cancer J Clin. 2016 Mar-Apr;66(2):96-114. doi: 10.3322/caac.21336. Epub 2016 Jan 21.
PubMed 26797525Kuntz KM, Lansdorp-Vogelaar I, Rutter CM, Knudsen AB, van Ballegooijen M, Savarino JE, Feuer EJ, Zauber AG. A systematic comparison of microsimulation models of colorectal cancer: the role of assumptions about adenoma progression. Med Decis Making. 2011 Jul-Aug;31(4):530-9. doi: 10.1177/0272989X11408730. Epub 2011 Jun 14.
PubMed 21673186Young GP, Symonds EL, Allison JE, Cole SR, Fraser CG, Halloran SP, Kuipers EJ, Seaman HE. Advances in Fecal Occult Blood Tests: the FIT revolution. Dig Dis Sci. 2015 Mar;60(3):609-22. doi: 10.1007/s10620-014-3445-3. Epub 2014 Dec 10.
PubMed 25492500Fedewa SA, Sauer AG, Siegel RL, Jemal A. Prevalence of major risk factors and use of screening tests for cancer in the United States. Cancer Epidemiol Biomarkers Prev. 2015 Apr;24(4):637-52. doi: 10.1158/1055-9965.EPI-15-0134.
PubMed 25834147Robertson DJ, Imperiale TF. Stool Testing for Colorectal Cancer Screening. Gastroenterology. 2015 Oct;149(5):1286-93. doi: 10.1053/j.gastro.2015.05.045. Epub 2015 May 30.
PubMed 26033632Allison JE. The best screening test for colorectal cancer is the one that gets done well. Gastrointest Endosc. 2010 Feb;71(2):342-5. doi: 10.1016/j.gie.2009.10.032. No abstract available.
PubMed 20152313Hawley ST, Volk RJ, Krishnamurthy P, Jibaja-Weiss M, Vernon SW, Kneuper S. Preferences for colorectal cancer screening among racially/ethnically diverse primary care patients. Med Care. 2008 Sep;46(9 Suppl 1):S10-6. doi: 10.1097/MLR.0b013e31817d932e.
PubMed 18725820Wolf RL, Basch CE, Brouse CH, Shmukler C, Shea S. Patient preferences and adherence to colorectal cancer screening in an urban population. Am J Public Health. 2006 May;96(5):809-11. doi: 10.2105/AJPH.2004.049684. Epub 2006 Mar 29.
PubMed 16571715Xu Y, Levy BT, Daly JM, Bergus GR, Dunkelberg JC. Comparison of patient preferences for fecal immunochemical test or colonoscopy using the analytic hierarchy process. BMC Health Serv Res. 2015 Apr 23;15:175. doi: 10.1186/s12913-015-0841-0.
PubMed 25902770Zauber AG, Lansdorp-Vogelaar I, Knudsen AB, Wilschut J, van Ballegooijen M, Kuntz KM. Evaluating test strategies for colorectal cancer screening: a decision analysis for the U.S. Preventive Services Task Force. Ann Intern Med. 2008 Nov 4;149(9):659-69. doi: 10.7326/0003-4819-149-9-200811040-00244. Epub 2008 Oct 6.
PubMed 18838717Zavoral M, Suchanek S, Majek O, Fric P, Minarikova P, Minarik M, Seifert B, Dusek L. Colorectal cancer screening: 20 years of development and recent progress. World J Gastroenterol. 2014 Apr 14;20(14):3825-34. doi: 10.3748/wjg.v20.i14.3825.
PubMed 24744575Centers for Disease Control and Prevention (CDC). Vital signs: colorectal cancer screening test use--United States, 2012. MMWR Morb Mortal Wkly Rep. 2013 Nov 8;62(44):881-8.
PubMed 24196665Zavoral M, Suchanek S, Zavada F, Dusek L, Muzik J, Seifert B, Fric P. Colorectal cancer screening in Europe. World J Gastroenterol. 2009 Dec 21;15(47):5907-15. doi: 10.3748/wjg.15.5907.
PubMed 20014454de Wijkerslooth TR, Stoop EM, Bossuyt PM, Meijer GA, van Ballegooijen M, van Roon AH, Stegeman I, Kraaijenhagen RA, Fockens P, van Leerdam ME, Dekker E, Kuipers EJ. Immunochemical fecal occult blood testing is equally sensitive for proximal and distal advanced neoplasia. Am J Gastroenterol. 2012 Oct;107(10):1570-8. doi: 10.1038/ajg.2012.249. Epub 2012 Jul 31.
PubMed 22850431Levi Z, Rozen P, Hazazi R, Vilkin A, Waked A, Maoz E, Birkenfeld S, Leshno M, Niv Y. A quantitative immunochemical fecal occult blood test for colorectal neoplasia. Ann Intern Med. 2007 Feb 20;146(4):244-55. doi: 10.7326/0003-4819-146-4-200702200-00003.
PubMed 17310048
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness of Fecal Immunochemical Tests With Optical Colonoscopy (R01 CA215034)
- ClinicalTrials.gov ID
- NCT03264898
- Acronym / sponsor ID
- BestFIT / IRB ID#201610814
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,761 participants (actual)
- Lead sponsor
- Barcey T. LevyUniversity, hospital or other
- Collaborators
- University of North Carolina, Texas Tech University Health Sciences Center
- Study start
- 2 Oct 2017 (actual)
- Primary completion
- 7 Mar 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 29 Aug 2017 (actual)
- 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.
Colorectal cancer is a preventable and/or a treatable cancer, but at least 43% of the United States population is not up-to-date with screening. Although 90% of colorectal cancer screening is done using colonoscopy, most other countries use fecal immunochemical tests, reserving colonoscopy for those with a positive fecal immunochemical test. This project will provide the foundation for a paradigm shift for colorectal cancer screening in the United States by identifying how well 5 different FITs work for detecting screening relevant neoplasia, thus reducing morbidity and mortality for colorectal cancer.
Detailed description
Colorectal cancer (CRC) is the third most common cancer and the third leading cause of cancer death in both men and women in the U.S., with nearly 50,000 deaths each year. Since CRC develops over a number of years from precursor lesions called polyps, it is largely detectable and preventable in early stages. As these polyps become larger, they, like most CRCs, tend to bleed, which is the rationale for the use of fecal occult blood tests (FOBTs) to detect both polyps and cancers early, while they are curable. However, early screening and detection is much less common than it could be, with about 43% of eligible individuals unscreened. Fecal immunochemical tests (FITs) are a type of FOBT that can be a sensitive, specific, and low cost alternative to colonoscopy for CRC screening. Modeling studies have shown that for population screening, a strategy of annual FIT testing from age of 50 to 75 years results in an equal number of life-years gained as compared with colonoscopy every 10 years. However, about 90% of screening in the U.S. is done with colonoscopy, the most expensive and invasive screening test. FITs are far less costly and largely replacing the guaiac test in CRC screening programs internationally, where only individuals with positive results are referred for a colonoscopy. Studies done on FITs in other countries often used FITs not available in the U.S. or studied high-risk populations; thus, results are not applicable in the U.S. It is critical to determine the FIT(s) with the best test characteristics in order to implement successful FIT-based screening programs in this country.
It is estimated that 24 million more individuals will need to be screened by 2018 to reach the "80% by 2018" goal set by the National Colorectal Cancer Roundtable. To address this knowledge gap, investigators propose to compare the test characteristics of three Clinical Laboratory Improvement Amendments (CLIA)-waived FITs and two automated FITs, using colonoscopy as the gold standard. The rationale for this proposed study is that, for almost all of the FITs currently marketed in the U.S., there is no evidence of the accuracy claimed. Specific aims are: Aim 1: To assess the diagnostic accuracy for advanced colorectal neoplasms of three of the most commonly used CLIA-waived FITs and two automated FITs, using colonoscopy as the gold standard.
Aim 2: To evaluate the diagnostic accuracy of two quantitative FITs using receiver operating characteristic (ROC) analysis. Aim 3: To assess factors associated with false positive and false negative FIT results for each device.
These findings will provide essential information about FITs with the best test characteristics for future expanded use of FIT, critically important to achieving the long-term goal of reducing morbidity and mortality from CRC. FITs are more acceptable to patients, will allow higher screening rates, and will reduce costs as compared with a screening strategy based on colonoscopy as the primary initial screening method.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal Immunochemical Test (FIT) Group | – | Device: Fecal immunochemical test (FIT)Each participant will complete 5 different FITs, on a single stool sample collected in a hat. Each participant will undergo optical colonoscopy and their FIT results compared with their colonoscopy with biopsy results (if applicable). We will calculate the test characteristics of each FIT. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients being scheduled for screening or surveillance colonoscopies meeting the study criteria at three academic health centers
Key inclusion criteria (1 listed)
- scheduled for a screening or surveillance colonoscopy
Key exclusion criteria (1 listed)
- familial polyposis syndromes: ulcerative colitis or Crohn's disease: or active rectal bleeding
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 test (FIT)FIT is a type of fecal occult blood test that uses antibodies to hemoglobin to detect blood in stool. | Device | Fecal Immunochemical Test (FIT) Group |
Primary outcome
Advanced adenoma or cancer as assessed by colonoscopy with biopsy if needed
Time frame: About 21 days from collection of FIT to performance of colonoscopy
Individual FIT brand results of negative, positive, or invalid
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2024.
- Background: PubMed 26797525Smith RA, Andrews K, Brooks D, DeSantis CE, Fedewa SA, Lortet-Tieulent J, Manassaram-Baptiste D, Brawley OW, Wender RC. Cancer screening in the United States, 2016: A review of current American Cancer Society guidelines and current issues in cancer screening. CA Cancer J Clin. 2016 Mar-Apr;66(2):96-114. doi: 10.3322/caac.21336. Epub 2016 Jan 21.
- Background: PubMed 21673186Kuntz KM, Lansdorp-Vogelaar I, Rutter CM, Knudsen AB, van Ballegooijen M, Savarino JE, Feuer EJ, Zauber AG. A systematic comparison of microsimulation models of colorectal cancer: the role of assumptions about adenoma progression. Med Decis Making. 2011 Jul-Aug;31(4):530-9. doi: 10.1177/0272989X11408730. Epub 2011 Jun 14.
- Background: PubMed 25492500Young GP, Symonds EL, Allison JE, Cole SR, Fraser CG, Halloran SP, Kuipers EJ, Seaman HE. Advances in Fecal Occult Blood Tests: the FIT revolution. Dig Dis Sci. 2015 Mar;60(3):609-22. doi: 10.1007/s10620-014-3445-3. Epub 2014 Dec 10.
- Background: PubMed 25834147Fedewa SA, Sauer AG, Siegel RL, Jemal A. Prevalence of major risk factors and use of screening tests for cancer in the United States. Cancer Epidemiol Biomarkers Prev. 2015 Apr;24(4):637-52. doi: 10.1158/1055-9965.EPI-15-0134.
- Background: PubMed 26033632Robertson DJ, Imperiale TF. Stool Testing for Colorectal Cancer Screening. Gastroenterology. 2015 Oct;149(5):1286-93. doi: 10.1053/j.gastro.2015.05.045. Epub 2015 May 30.
- Background: PubMed 20152313Allison JE. The best screening test for colorectal cancer is the one that gets done well. Gastrointest Endosc. 2010 Feb;71(2):342-5. doi: 10.1016/j.gie.2009.10.032. No abstract available.
- Background: PubMed 18725820Hawley ST, Volk RJ, Krishnamurthy P, Jibaja-Weiss M, Vernon SW, Kneuper S. Preferences for colorectal cancer screening among racially/ethnically diverse primary care patients. Med Care. 2008 Sep;46(9 Suppl 1):S10-6. doi: 10.1097/MLR.0b013e31817d932e.
- Background: PubMed 16571715Wolf RL, Basch CE, Brouse CH, Shmukler C, Shea S. Patient preferences and adherence to colorectal cancer screening in an urban population. Am J Public Health. 2006 May;96(5):809-11. doi: 10.2105/AJPH.2004.049684. Epub 2006 Mar 29.
- Background: PubMed 25902770Xu Y, Levy BT, Daly JM, Bergus GR, Dunkelberg JC. Comparison of patient preferences for fecal immunochemical test or colonoscopy using the analytic hierarchy process. BMC Health Serv Res. 2015 Apr 23;15:175. doi: 10.1186/s12913-015-0841-0.
- Background: PubMed 18838717Zauber AG, Lansdorp-Vogelaar I, Knudsen AB, Wilschut J, van Ballegooijen M, Kuntz KM. Evaluating test strategies for colorectal cancer screening: a decision analysis for the U.S. Preventive Services Task Force. Ann Intern Med. 2008 Nov 4;149(9):659-69. doi: 10.7326/0003-4819-149-9-200811040-00244. Epub 2008 Oct 6.
- Background: PubMed 24744575Zavoral M, Suchanek S, Majek O, Fric P, Minarikova P, Minarik M, Seifert B, Dusek L. Colorectal cancer screening: 20 years of development and recent progress. World J Gastroenterol. 2014 Apr 14;20(14):3825-34. doi: 10.3748/wjg.v20.i14.3825.
- Background: PubMed 24196665Centers for Disease Control and Prevention (CDC). Vital signs: colorectal cancer screening test use--United States, 2012. MMWR Morb Mortal Wkly Rep. 2013 Nov 8;62(44):881-8.
- Individual participant dataSharing planned: Yes. Once the key publications are accepted and finalized, de-identified data and the codebook will be made available to anyone with a legitimate request who follows the Data Sharing agreement.
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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.
Barcey T Levy, PhD, MD principal investigator
University of Iowa
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Cancer, run by Barcey T. Levy 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 Aug 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Advanced adenoma or cancer as assessed by colonoscopy with biopsy if needed (time frame: About 21 days from collection of FIT to performance of colonoscopy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03264898, which also lists 27 linked publications.
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 2 Aug 2024.