Colorectal NeoplasmsNCT05440552
Evaluation of Colorectal Cancer Screening Strategies in China
A study testing Qualitative Fecal immunochemical test + APCS score and Quantitative Fecal immunochemical test in people with Colorectal Neoplasms, run by Shandong University.
Trial summary
A large-scale randomized controlled trial was conducted to compare different colorectal neoplasms screening strategies in China. Read more about this study
- Who is it for?
- Ages 50 to 74 years
- Conditions the study is for
- Colorectal Neoplasms
- What is being tested?
- Qualitative Fecal immunochemical test + APCS score and Quantitative Fecal immunochemical test
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20,000 participants
- Where
- No sites listed yet
- Study dates
- Jul 2022to Dec 2023
- 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 50 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 50-74 years old
- Informed consent is available
Who cannot join
- Previous colorectal cancer
- Previous colorectal resection
- Previous received cancer-related treatment (except non-melanoma skin cancer)
- Colonoscopy, sigmoidoscopy, CT colonoscopy, and barium enema were performed within 5 years
- Fecal occult blood or fecal DNA was performed within one year
- Symptoms of lower digestive tract diseases requiring colonoscopy include: (1) rectal bleeding occurred more than once in the past 6 months, (2) recorded iron deficiency anemia, and (3) recorded significant weight loss within 6 months (> 10% of baseline weight - Suffering from other diseases that affect the benefit of screening or intolerance to colonoscopy (for example, severe pulmonary disease, end-stage renal disease, end-stage liver disease, severe heart failure or recently diagnosed cancer, except non-melanoma skin cancer)
About this study
Official title: Evaluation of Colorectal Cancer Screening Strategies in China：A Prospective Randomized Trial
A large-scale randomized controlled trial was conducted to compare different colorectal neoplasms screening strategies in China.
- Conditions
- Colorectal Neoplasms
- Being tested
- Qualitative Fecal immunochemical test + APCS score, 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.
Qualitative Fecal immunochemical test + APCS scoreDiagnostic test
Risk stratification using Qualitative Fecal immunochemical test and APCS score
Quantitative Fecal immunochemical testDiagnostic test
Use Quantitative Fecal immunochemical only for risk stratification
| Study group | Role | What they receive |
|---|---|---|
| Risk score1 | Placebo comparator | Not described Receives: Diagnostic Test: Qualitative Fecal immunochemical test + APCS score |
| Risk score2 | Active comparator | Not described Receives: Diagnostic Test: Quantitative Fecal immunochemical test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection rate
Detection of intestinal lesions
Measured: up to 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2022
- Study startJul 2022 (estimated)
- Primary completionSep 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanqing Li, Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05440552
- Sponsor's protocol ID
- 2022SDU-QILU-107
- Status last verified
- Jun 2022
- First submitted
- 23 Jun 2022
- Last updated
- 1 Jul 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 1 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Colorectal Cancer Screening Strategies in China：A Prospective Randomized Trial
- ClinicalTrials.gov ID
- NCT05440552
- Acronym / sponsor ID
- 2022SDU-QILU-107
- Conditions
- Colorectal Neoplasms
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20,000 participants (estimated)
- Lead sponsor
- Shandong UniversityUniversity, hospital or other
- Study start
- Jul 2022 (estimated)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 1 Jul 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.
A large-scale randomized controlled trial was conducted to compare different colorectal neoplasms screening strategies in China.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Risk score1 | Placebo comparator | Diagnostic Test: Qualitative Fecal immunochemical test + APCS score |
| Risk score2 | Active comparator | Diagnostic Test: Quantitative Fecal immunochemical test |
Who may qualify
- Ages
- 50 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 50-74 years old
- Informed consent is available
Key exclusion criteria (6 listed)
- Previous colorectal cancer
- Previous colorectal resection
- Previous received cancer-related treatment (except non-melanoma skin cancer)
- Colonoscopy, sigmoidoscopy, CT colonoscopy, and barium enema were performed within 5 years
- Fecal occult blood or fecal DNA was performed within one year
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 |
|---|---|---|
| Qualitative Fecal immunochemical test + APCS scoreRisk stratification using Qualitative Fecal immunochemical test and APCS score | Diagnostic test | Risk score1 |
| Quantitative Fecal immunochemical testUse Quantitative Fecal immunochemical only for risk stratification | Diagnostic test | Risk score2 |
Primary outcome
Detection rate
Time frame: up to 30 months
Detection of intestinal lesions
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Qualitative Fecal immunochemical test + APCS score and Quantitative Fecal immunochemical test in people with Colorectal Neoplasms, run by Shandong University.
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 1 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
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?
Detection rate (time frame: up to 30 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 1 Jul 2022.