Colorectal CancerNCT04454099
A Comparison of Different Fecal Occult Blood Test for Colorectal Cancer Screening
An observational study of Colorectal Cancer, run by Shandong University at 1 site in China.
Trial summary
Colorectal cancer is a leading cause of cancer-related morbidity and mortality. CRC-related death can be prevented through fecal occult blood test screening. Because of economic and high sensitivity, fecal immunochemical test is recommended for screening population of CRC. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- 4 kind of FOBT and colonoscopy with pathological examination
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to 18 Mar 2021
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Continuous participants intending to undergo colonoscopy and meet the inclusion and exclusion criteria from Qilu Hospital were enrolled.
Who may be able to join
- Adults 50-75 years old;
- Asia-Pacific Colorectal Screening score(APCS): medium or high risk.
Who cannot join
- APCS score: low risk;
- People with history of intestinal surgery;
- People with history of CRC;
- People with history of inflammatory bowel disease, ischemic enteritis, vascular malformation of intestine or other disease resulting in intestinal tract bleeding;
- People with symptoms including visible rectal bleeding, hematuria, severe and acute diarrhea and Bristol feces score 7th type;
- Pregnancy, lactation or menstrual phase;
- Severe congestive heart failure or other sever disease cause cannot tolerate colonoscopy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of Quantitative Fecal Immunochemical Test and Qualitative Fecal Occult Blood Test for Colorectal Cancer Screening in Medium and High Risk Screening Population
Colorectal cancer is a leading cause of cancer-related morbidity and mortality. CRC-related death can be prevented through fecal occult blood test screening. Because of economic and high sensitivity, fecal immunochemical test is recommended for screening population of CRC. The purpose of this study is to compare the accuracy of 4 different fecal occult blood testing in medium and high risk screening population in Chinese.
Read the detailed description
Colorectal cancer (CRC) is one of the most common cancer worldwide, and cause a huge number of cancer-associated mortality. CRC screening has been shown to be effective in reducing the incidence of, and mortality from, CRC. There are several recommended screening options for screening population of CRC, including colonoscopy and fecal occult blood testing (FOBT) .Colonoscopy has higher sensitivity and specificity than FOBT for detecting advanced colorectal neoplasia but also has several disadvantages, including higher cost and poorer compliance. Therefore, many patients prefer FOBT to colonoscopy. FOBT includes guaiac-based fecal occult blood test (gFOBT) and fecal immunochemical test (FIT). FIT includes quantitative FIT (qFIT) and qualitative FIT. qFIT can provide a value of concentration of hemoglobin in stool and are increasingly recommended for CRC. In China, the most common use FOBT is qualitative FIT and the comparison of quantitative and qualitative FIT is lack in screening population of CRC in Chinese. To add to the evidence on FIT performance characteristics for detection of CRC, the investigators design this research to compare qFIT with other 3 qualitative FOBT（two of them are colloidal gold qualitative FITs and one of them is chemical and immunologic combined detection）in medium and high risk screening population.
- Conditions
- Colorectal Cancer
- Being tested
- 4 kind of FOBT and colonoscopy with pathological examination
- Keywords
- Colorectal cancer, fecal occult blood testing, quantitative fecal immunochemical test
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
4 kind of FOBT and colonoscopy with pathological examinationDiagnostic test
Detect Hb in stool by 4 kind of FOBT and detect colon lesion using colonoscopy and pathological examination.
| Study group | Role | What they receive |
|---|---|---|
| Fecal Occult Blood Test | People in this group will use four kind of fecal occult blood test, including quantitative and qualitative method, to detect Hb in stool before colonoscopy. Receives: Diagnostic Test: 4 kind of FOBT and colonoscopy with pathological examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
The accuracy of 4 kind of FOBTs to diagnose CRC.
The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect CRC.
Measured: 6 months
The accuracy of 4 kind of FOBTs to diagnose advanced colorectal neoplasm.
The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced colorectal neoplasm.
Measured: 6 months
The accuracy of 4 kind of FOBTs to diagnose advanced adenoma.
The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced adenoma.
Measured: 6 months
Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT.
Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT, age ,sex, CRC family history and so on.
Measured: 6 months
Secondary outcomes (3)
Explore the cost-benefit ratio of one or two-sample of qFIT.
Explore the cost-benefit ratio of one or two-sample of qFIT.
Measured: 6 month
Explore the reason of false positive of qFIT
Calculate false positive rate of the 4 kind of FOBTs. and count the case number of inflammatory bowel disease, colonic diverticulitis, hemorrhoids, upper gastrointestinal disease or medical factors that cause false positive of qFIT.
Measured: 6 month
Explore the effect of aspirin or other anticoagulants to the diagnose accuracy of qFIT
Count sensitivity and specificity with or without patients who take aspirin or other anticoagulants.
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Jul 2020
- Primary completion18 Mar 2021
- Study completion18 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Other
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Yanqing Li, PhD, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04454099
- Sponsor's protocol ID
- 2020SDU-QILU-524
- Status last verified
- May 2021
- First submitted
- 9 Jun 2020
- Last updated
- 4 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Robertson DJ, Lee JK, Boland CR, Dominitz JA, Giardiello FM, Johnson DA, Kaltenbach T, Lieberman D, Levin TR, Rex DK. Recommendations on Fecal Immunochemical Testing to Screen for Colorectal Neoplasia: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2017 Apr;152(5):1217-1237.e3. doi: 10.1053/j.gastro.2016.08.053. Epub 2016 Oct 19.
PubMed 27769517Mirza IA, Meng FY, Han Z, Wang PZ, Li YY, Zhang Y, Ma MJ, Zuo XL, Li YQ, Zhou RC. Risk factors associated with false-positive fecal immunochemical test results in colorectal cancer screening. Sci Rep. 2026 Feb 19;16(1):9794. doi: 10.1038/s41598-026-40251-w.
PubMed 41714770
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Quantitative Fecal Immunochemical Test and Qualitative Fecal Occult Blood Test for Colorectal Cancer Screening in Medium and High Risk Screening Population
- ClinicalTrials.gov ID
- NCT04454099
- Acronym / sponsor ID
- 2020SDU-QILU-524
- Conditions
- Colorectal Cancer
- Keywords
- Colorectal cancer, fecal occult blood testing, quantitative fecal immunochemical test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 18 Mar 2021 (actual)
- Study completion
- 18 Mar 2021 (actual)
- First posted
- 1 Jul 2020 (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 leading cause of cancer-related morbidity and mortality. CRC-related death can be prevented through fecal occult blood test screening. Because of economic and high sensitivity, fecal immunochemical test is recommended for screening population of CRC. The purpose of this study is to compare the accuracy of 4 different fecal occult blood testing in medium and high risk screening population in Chinese.
Detailed description
Colorectal cancer (CRC) is one of the most common cancer worldwide, and cause a huge number of cancer-associated mortality. CRC screening has been shown to be effective in reducing the incidence of, and mortality from, CRC. There are several recommended screening options for screening population of CRC, including colonoscopy and fecal occult blood testing (FOBT) .Colonoscopy has higher sensitivity and specificity than FOBT for detecting advanced colorectal neoplasia but also has several disadvantages, including higher cost and poorer compliance. Therefore, many patients prefer FOBT to colonoscopy. FOBT includes guaiac-based fecal occult blood test (gFOBT) and fecal immunochemical test (FIT). FIT includes quantitative FIT (qFIT) and qualitative FIT. qFIT can provide a value of concentration of hemoglobin in stool and are increasingly recommended for CRC. In China, the most common use FOBT is qualitative FIT and the comparison of quantitative and qualitative FIT is lack in screening population of CRC in Chinese. To add to the evidence on FIT performance characteristics for detection of CRC, the investigators design this research to compare qFIT with other 3 qualitative FOBT（two of them are colloidal gold qualitative FITs and one of them is chemical and immunologic combined detection）in medium and high risk screening population.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal Occult Blood Test | – | Diagnostic Test: 4 kind of FOBT and colonoscopy with pathological examinationPeople in this group will use four kind of fecal occult blood test, including quantitative and qualitative method, to detect Hb in stool before colonoscopy. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Continuous participants intending to undergo colonoscopy and meet the inclusion and exclusion criteria from Qilu Hospital were enrolled.
Key inclusion criteria (2 listed)
- Adults 50-75 years old;
- Asia-Pacific Colorectal Screening score(APCS): medium or high risk.
Key exclusion criteria (7 listed)
- APCS score: low risk;
- People with history of intestinal surgery;
- People with history of CRC;
- People with history of inflammatory bowel disease, ischemic enteritis, vascular malformation of intestine or other disease resulting in intestinal tract bleeding;
- People with symptoms including visible rectal bleeding, hematuria, severe and acute diarrhea and Bristol feces score 7th type;
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 |
|---|---|---|
| 4 kind of FOBT and colonoscopy with pathological examinationDetect Hb in stool by 4 kind of FOBT and detect colon lesion using colonoscopy and pathological examination. | Diagnostic test | Fecal Occult Blood Test |
Primary outcome
The accuracy of 4 kind of FOBTs to diagnose CRC.
Time frame: 6 months
The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect CRC.
The accuracy of 4 kind of FOBTs to diagnose advanced colorectal neoplasm.
Time frame: 6 months
The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced colorectal neoplasm.
The accuracy of 4 kind of FOBTs to diagnose advanced adenoma.
Time frame: 6 months
The sensitivity, specificity, positive predictive value and negative predictive value of these 4 FOBTs to detect advanced adenoma.
Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT.
Time frame: 6 months
Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT, age ,sex, CRC family history and so on.
3 secondary outcomes
Explore the cost-benefit ratio of one or two-sample of qFIT.
Time frame: 6 month
Explore the reason of false positive of qFIT
Time frame: 6 month
Explore the effect of aspirin or other anticoagulants to the diagnose accuracy of qFIT
Time frame: 6 month
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 4 May 2021.
- Background: PubMed 27769517Robertson DJ, Lee JK, Boland CR, Dominitz JA, Giardiello FM, Johnson DA, Kaltenbach T, Lieberman D, Levin TR, Rex DK. Recommendations on Fecal Immunochemical Testing to Screen for Colorectal Neoplasia: A Consensus Statement by the US Multi-Society Task Force on Colorectal Cancer. Gastroenterology. 2017 Apr;152(5):1217-1237.e3. doi: 10.1053/j.gastro.2016.08.053. Epub 2016 Oct 19.
- Derived from this study: PubMed 41714770Mirza IA, Meng FY, Han Z, Wang PZ, Li YY, Zhang Y, Ma MJ, Zuo XL, Li YQ, Zhou RC. Risk factors associated with false-positive fecal immunochemical test results in colorectal cancer screening. Sci Rep. 2026 Feb 19;16(1):9794. doi: 10.1038/s41598-026-40251-w.
- Individual participant dataSharing planned: Undecided
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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.
Yanqing Li, PhD study chair
Qilu Hospital of Shandong University
1 site 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 Shandong University at 1 site in China.
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 2 inclusion and 7 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 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The accuracy of 4 kind of FOBTs to diagnose CRC. (time frame: 6 months). The study lists 4 primary outcomes in all. 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 NCT04454099, which also lists 2 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 4 May 2021.