Colorectal NeoplasmNCT04856423
Ultra-sensitivity Quantitative Fecal Immunochemical Test in Detecting Colorectal Advanced Adenoma and Colorectal Cancer
An observational study of Colorectal Neoplasm, run by Shandong University at 6 sites in China.
Trial summary
Early detecting and removing of colorectal advanced adenomas can reduce the incidence of colorectal cancer. Because of the less bleeding of advanced adenomas, sensitivities of the common used quantitative fecal immunochemical tests (qFITs) are unsatisfying. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Colorectal Neoplasm
- What is being tested?
- The us-qFIT and colonoscopy with pathological examination
- How many people
- 6,000 participants
- Where
- 6 sitesChina
- Study dates
- 19 Apr 2021to 30 Jun 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 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 the 5 hospitals were enrolled.
Who may be able to join
- 50-75 years old people;
- People sign an "informed consent form"
Who cannot join
- People with history of colorectal surgery;
- People with history of colorectal cancer;
- People with history of other diseases that may produce fecal blood, such as inflammatory bowel disease, ischemic enteritis, vascular alformation of intestine, intestinal tuberculosis or Non-Hodgkin's lymphoma involving digestive tract;
- People with symptoms including visible rectal bleeding, hematuria, hemorrhoid bleeds, severe and acute diarrhea and watery stool;
- People are in pregnancy, lactation or menstrual phase;
- People with severe congestive heart failure or other sever disease cause cannot tolerate colonoscopy.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Binzhou Medical University Hospotal
Binzhou, Shandong
Chengxia Liu
- Recruiting
People's Hospital of Lixia District of Jinan
Jinan, Shandong, 250012
Hongjun LiZhang, +8613515415912
- Recruiting
Qilu Hospital of Shandong University
Jinan, Shandong
Yanqing Li
- Recruiting
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality
Shuzhang Xu
- Recruiting
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality
Bangmao Wang
- Recruiting
Weihai Municipal Hospital
Weihai, Shandong
Xiaozhong Gao
About this study
Official title: Ultra-sensitivity Quantitative Fecal Immunochemical Test Improve Diagnostic Accuracy in Detecting Colorectal Advanced Adenoma and Colorectal Cancer: a Multicenter, Prospective Study
Early detecting and removing of colorectal advanced adenomas can reduce the incidence of colorectal cancer. Because of the less bleeding of advanced adenomas, sensitivities of the common used quantitative fecal immunochemical tests (qFITs) are unsatisfying. Ultra-sensitivity qFIT(us-qFIT) can determine extremely low fecal hemoglobin concentration compared with the common used qFIT. This study will prove the diagnostic accuracy of us-qFIT in detecting colorectal advanced adenomas.
Read the detailed description
Early detection of CRC in a curable stage can reduce mortality but not morbidity. The majority of colorectal cancer is thought to arise from precancerous lesions through the adenoma-carcinoma pathway. Detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. Although colonoscopy is currently considered the most effective method for detecting advanced adenomas, individuals may be reluctant to undergo colonoscopy due to the uncomfortable feeling and the relatively high cost. Conversely, stool tests are relatively cheap and more readily accepted. Fecal immunochemical test (FIT) is economic and easy to use in colorectal cancer screening. However, the common used qFIT is insufficiently sensitive to the minor hemorrhage of advanced adenomas, and the sensitivity is about only 27% to 47%. To improve the detection rate of colorectal advanced adenoma, Ultra-sensitivity quantitative fecal immunochemical test (us-qFIT) improves technology and can detect fecal hemoglobin in extremely low concentration quantificationally. The investigators design this research to prove the diagnostic accuracy of us-qFIT in detecting colorectal advanced adenoma.
- Conditions
- Colorectal Neoplasm
- Being tested
- The us-qFIT and colonoscopy with pathological examination
- Keywords
- Colorectal Neoplasm, Occult Bleeding, Quantitative fecal immunochemical test, Colorectal Cancer, Adenoma
- Medical subject headings
- Colorectal Neoplasms, Adenoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The us-qFIT and colonoscopy with pathological examinationDiagnostic test
Detect fecal hemoglobin concentration by us-qFIT before colonoscopy, detect colon lesions using colonoscopy and pathological examination.
| Study group | Role | What they receive |
|---|---|---|
| Us-qFIT group | People in this group will detect fecal hemoglobin concentration by us-qFIT before colonoscopy. Receives: Diagnostic Test: The us-qFIT 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 us-qFIT to diagnose colorectal advanced adenoma.
The sensitivity, specificity, positive predictive value and negative predictive value.
Measured: 24 months
Secondary outcomes (3)
The accuracy of us-qFIT to diagnose colorectal cancer.
The sensitivity, specificity, positive predictive value and negative predictive value.
Measured: 24 months
The accuracy of us-qFIT to diagnose high-risk adenoma.
The sensitivity, specificity, positive predictive value and negative predictive value.
Measured: 24 months
Develop a predictive model of advanced colorectal neoplasms which includes the value of us-qFIT.
Develop a predictive model of CRC or advanced colorectal neoplasm which includes qFIT, age ,sex, CRC family history, diet and so on.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2021
- Study start19 Apr 2021
- Primary completion19 Apr 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmStudies 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
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine, Tianjin Medical University General Hospital, Binzhou Medical University, Weihai Municipal Hospital, People's Hospital of Lixia District of Jinan
- 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
- NCT04856423
- Sponsor's protocol ID
- 2020SDU-QILU-1026
- Status last verified
- Sep 2021
- First submitted
- 19 Apr 2021
- Last updated
- 16 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultra-sensitivity Quantitative Fecal Immunochemical Test Improve Diagnostic Accuracy in Detecting Colorectal Advanced Adenoma and Colorectal Cancer: a Multicenter, Prospective Study
- ClinicalTrials.gov ID
- NCT04856423
- Acronym / sponsor ID
- 2020SDU-QILU-1026
- Conditions
- Colorectal Neoplasm
- Keywords
- Colorectal Neoplasm, Occult Bleeding, Quantitative fecal immunochemical test, Colorectal Cancer, Adenoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Collaborators
- Shanghai Tongji Hospital, Tongji University School of Medicine, Tianjin Medical University General Hospital, Binzhou Medical University, Weihai Municipal Hospital, People's Hospital of Lixia District of Jinan
- Study start
- 19 Apr 2021 (actual)
- Primary completion
- 19 Apr 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 23 Apr 2021 (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.
Early detecting and removing of colorectal advanced adenomas can reduce the incidence of colorectal cancer. Because of the less bleeding of advanced adenomas, sensitivities of the common used quantitative fecal immunochemical tests (qFITs) are unsatisfying. Ultra-sensitivity qFIT(us-qFIT) can determine extremely low fecal hemoglobin concentration compared with the common used qFIT. This study will prove the diagnostic accuracy of us-qFIT in detecting colorectal advanced adenomas.
Detailed description
Early detection of CRC in a curable stage can reduce mortality but not morbidity. The majority of colorectal cancer is thought to arise from precancerous lesions through the adenoma-carcinoma pathway. Detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer. Although colonoscopy is currently considered the most effective method for detecting advanced adenomas, individuals may be reluctant to undergo colonoscopy due to the uncomfortable feeling and the relatively high cost. Conversely, stool tests are relatively cheap and more readily accepted. Fecal immunochemical test (FIT) is economic and easy to use in colorectal cancer screening. However, the common used qFIT is insufficiently sensitive to the minor hemorrhage of advanced adenomas, and the sensitivity is about only 27% to 47%. To improve the detection rate of colorectal advanced adenoma, Ultra-sensitivity quantitative fecal immunochemical test (us-qFIT) improves technology and can detect fecal hemoglobin in extremely low concentration quantificationally. The investigators design this research to prove the diagnostic accuracy of us-qFIT in detecting colorectal advanced adenoma.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Us-qFIT group | – | Diagnostic Test: The us-qFIT and colonoscopy with pathological examinationPeople in this group will detect fecal hemoglobin concentration by us-qFIT 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 the 5 hospitals were enrolled.
Key inclusion criteria (2 listed)
- 50-75 years old people;
- People sign an "informed consent form"
Key exclusion criteria (6 listed)
- People with history of colorectal surgery;
- People with history of colorectal cancer;
- People with history of other diseases that may produce fecal blood, such as inflammatory bowel disease, ischemic enteritis, vascular alformation of intestine, intestinal tuberculosis or Non-Hodgkin's lymphoma involving digestive tract;
- People with symptoms including visible rectal bleeding, hematuria, hemorrhoid bleeds, severe and acute diarrhea and watery stool;
- People are in pregnancy, lactation or menstrual phase;
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 |
|---|---|---|
| The us-qFIT and colonoscopy with pathological examinationDetect fecal hemoglobin concentration by us-qFIT before colonoscopy, detect colon lesions using colonoscopy and pathological examination. | Diagnostic test | Us-qFIT group |
Primary outcome
The accuracy of us-qFIT to diagnose colorectal advanced adenoma.
Time frame: 24 months
The sensitivity, specificity, positive predictive value and negative predictive value.
3 secondary outcomes
The accuracy of us-qFIT to diagnose colorectal cancer.
Time frame: 24 months
The accuracy of us-qFIT to diagnose high-risk adenoma.
Time frame: 24 months
Develop a predictive model of advanced colorectal neoplasms which includes the value of us-qFIT.
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2021.
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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
6 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 Neoplasm, run by Shandong University at 6 sites 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 6 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 16 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ruchen Zhou, MD (15949702165, sdlwzrc@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The accuracy of us-qFIT to diagnose colorectal advanced adenoma. (time frame: 24 months). 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 16 Sep 2021.