Colorectal CancerNCT05232721
Evaluation of a Point-of-care Testing Instrument for Fecal Immunochemical Test
An observational study of Colorectal Cancer, run by Shandong University at 1 site in China.
Trial summary
Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer.Use of the fecal immunochemical test (FIT) for colorectal cancer (CRC) prevention is supported by previous studies.However existing instruments have low portability.The purpose of this study is to test the… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- The new instrument and colonoscopy with pathological examination
- How many people
- 275 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2022to 20 Apr 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: People who use the new instrument for Fecal Immunochemical Test.
Who may be able to join
- People who use the new instrument for fecal immunochemical test(FIT)
- People sign an "informed consent form"
Who cannot join
- People with history of surgery in any part of the large bowel;
- People with symptoms including visible rectal bleeding, hematuria, hemorrhoid bleeds, severe and acute diarrhea and 7th type stool (Bristol feces score);
Trial locations and contacts
1 site in 1 country.
China1 site
Qilu Hospital
Jinan, Shandong, 250014
Song yihao, BD, 15098739370, 1019038804@qq.com
About this study
Early detecting and removing of colorectal advanced adenomas can reduce incidence of colorectal cancer.Use of the fecal immunochemical test (FIT) for colorectal cancer (CRC) prevention is supported by previous studies.However existing instruments have low portability.The purpose of this study is to test the performance of a Point-of-care testing instrument for fecal Immunochemical test(FIT) .
Read the detailed description
Colorectal cancer (CRC) is the third most common cancer worldwide and has become a progressively important public health problem that inevitably leads to an increase in morbidity and medical costs. Therefore, many countries have a screening program in place to lower the incidence of CRC. Subjects with a positive fecal immunochemical test (FIT) have a much higher likelihood of advanced neoplasms than the general population.However existing instruments have low portability.The purpose of this study is to test the performance of a Point-of-care testing instrument for fecal immunochemical test (FIT).
- Conditions
- Colorectal Cancer
- Being tested
- The new instrument and colonoscopy with pathological examination
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The new instrument and colonoscopy with pathological examinationDiagnostic test
Detect hemoglobin in stool by the point-of-care testing instrument before colonoscopy, detect colon lesion using colonoscopy and pathological examination.
| Study group | Role | What they receive |
|---|---|---|
| Fecal Immunochemical Test | People in this group will detect hemoglobin in stool before colonoscopy by the new instrument Receives: Diagnostic Test: The new instrument and colonoscopy with pathological examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnostic performance of advanced neoplasms
The study is committed to test the diagnostic efficacy of the new instrument to advanced neoplasms.We will measure the sensitivity and specificity of the instrument
Measured: 4 months
Secondary outcomes (1)
Diagnostic performance of Colorectal Cancer
The study is committed to test the diagnostic efficacy of the new instrument to colorectal cancer.We will measure the sensitivity and specificity of the instrument
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start20 Feb 2022 (estimated)
- Primary completion1 Apr 2022 (estimated)
- Study completion20 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
- Investigators
- Li yanqing, Professor, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05232721
- Sponsor's protocol ID
- 2022SDU-QILU-105
- Status last verified
- Feb 2022
- First submitted
- 6 Jan 2022
- Last updated
- 10 Feb 2022
- 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 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Point-of-care Testing Instrument for Fecal Immunochemical Test
- ClinicalTrials.gov ID
- NCT05232721
- Acronym / sponsor ID
- 2022SDU-QILU-105
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- 20 Feb 2022 (estimated)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 20 Apr 2022 (estimated)
- First posted
- 10 Feb 2022 (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 incidence of colorectal cancer.Use of the fecal immunochemical test (FIT) for colorectal cancer (CRC) prevention is supported by previous studies.However existing instruments have low portability.The purpose of this study is to test the performance of a Point-of-care testing instrument for fecal Immunochemical test(FIT) .
Detailed description
Colorectal cancer (CRC) is the third most common cancer worldwide and has become a progressively important public health problem that inevitably leads to an increase in morbidity and medical costs. Therefore, many countries have a screening program in place to lower the incidence of CRC. Subjects with a positive fecal immunochemical test (FIT) have a much higher likelihood of advanced neoplasms than the general population.However existing instruments have low portability.The purpose of this study is to test the performance of a Point-of-care testing instrument for fecal immunochemical test (FIT).
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fecal Immunochemical Test | – | Diagnostic Test: The new instrument and colonoscopy with pathological examinationPeople in this group will detect hemoglobin in stool before colonoscopy by the new instrument |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- People who use the new instrument for Fecal Immunochemical Test.
Key inclusion criteria (2 listed)
- People who use the new instrument for fecal immunochemical test(FIT)
- People sign an "informed consent form"
Key exclusion criteria (2 listed)
- People with history of surgery in any part of the large bowel;
- People with symptoms including visible rectal bleeding, hematuria, hemorrhoid bleeds, severe and acute diarrhea and 7th type stool (Bristol feces score);
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 new instrument and colonoscopy with pathological examinationDetect hemoglobin in stool by the point-of-care testing instrument before colonoscopy, detect colon lesion using colonoscopy and pathological examination. | Diagnostic test | Fecal Immunochemical Test |
Primary outcome
Diagnostic performance of advanced neoplasms
Time frame: 4 months
The study is committed to test the diagnostic efficacy of the new instrument to advanced neoplasms.We will measure the sensitivity and specificity of the instrument
1 secondary outcome
Diagnostic performance of Colorectal Cancer
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
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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.
Li yanqing, Professor 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 2 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 10 Feb 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Song yihao, BD (15098739370, 1019038804@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnostic performance of advanced neoplasms (time frame: 4 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 10 Feb 2022.