Colorectal CancerNCT06785714
Colorectal Cancer Screening in Xinxiang City
An observational study of Colorectal Cancer, run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
Trial summary
The primary objective of this study is to evaluate the sensitivity of the fecal protein dual-index test reagent for the detection of colorectal cancer (CRC). Read more about this study
- Who is it for?
- Ages 45 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Cancer
- How many people
- 25,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2024to 15 Jan 2025
- 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 45 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Single cohort of patients aged between 45 and 84, with no known high risk features, undergoing routine colorectal cancer screening as standard of care.
Who may be able to join
- Subjects aged 45-74 years at time of consent
- Have not had gastrointestinal resection
Who cannot join
- Previous history of colorectal cancer
- Patients who have been confirmed to have other malignant neoplastic diseases of the digestive system
- Patients with severe heart, brain, lung disease or liver and kidney dysfunction or insufficiency
- Those with severe mental disorders and language communication disorders
- History of contraindications to colonoscopy
- Pregnant women
Trial locations and contacts
1 site in 1 country.
China1 site
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100
About this study
The primary objective of this study is to evaluate the sensitivity of the fecal protein dual-index test reagent for the detection of colorectal cancer (CRC).
Read the detailed description
The project uses fecal hemoglobin and transferrin dual-index combined with reagents that can be self-tested at home (referred to as fecal protein dual-index detection reagents), combined with colorectal cancer risk factor questionnaires, to carry out colorectal cancer screening in people of specific ages in the city, aiming to achieve early screening, early diagnosis and early treatment, and evaluate the effect of fecal protein dual-index detection reagents in early screening of colorectal cancer, so as to provide a scientific basis for optimizing the national screening program.
- Conditions
- Colorectal Cancer
- Medical subject headings
- Colorectal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of colorectal cancer detection
Sensitivity of colorectal cancer detection
Measured: 180 days
Specificity of advanced neoplasia detection
Specificity of advanced neoplasia detection
Measured: 180 days
Secondary outcomes (3)
Positive predictive value of colorectal cancer detection
Positive predictive value of colorectal cancer detection
Measured: 180 days
Negative predictive value of colorectal cancer detection
Negative predictive value of colorectal cancer detection
Measured: 180 days
Sensitivity and specificity of advanced adenoma detection
Sensitivity and specificity of advanced adenoma detection
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2025
- Study start1 Sep 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Collaborators
- Xinxiang Municipal Health Commission, Xinjiang Center for Disease Control and Prevention, Xinxiang Central Hospital, The Affiliated People's Hospital of Xinxiang Medical University, The Third Affiliated Hospital of Xinxiang Medical College, Shanghai Jiao Tong University School of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06785714
- Sponsor's protocol ID
- Chase 008
- Status last verified
- Jan 2025
- First submitted
- 15 Jan 2025
- Last updated
- 21 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Colorectal Cancer Screening in Xinxiang City
- ClinicalTrials.gov ID
- NCT06785714
- Acronym / sponsor ID
- Chase 008
- Conditions
- Colorectal Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25,000 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Collaborators
- Xinxiang Municipal Health Commission, Xinjiang Center for Disease Control and Prevention, Xinxiang Central Hospital, The Affiliated People's Hospital of Xinxiang Medical University, The Third Affiliated Hospital of Xinxiang Medical College, Shanghai Jiao Tong University School of Medicine
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 21 Jan 2025 (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.
The primary objective of this study is to evaluate the sensitivity of the fecal protein dual-index test reagent for the detection of colorectal cancer (CRC).
Detailed description
The project uses fecal hemoglobin and transferrin dual-index combined with reagents that can be self-tested at home (referred to as fecal protein dual-index detection reagents), combined with colorectal cancer risk factor questionnaires, to carry out colorectal cancer screening in people of specific ages in the city, aiming to achieve early screening, early diagnosis and early treatment, and evaluate the effect of fecal protein dual-index detection reagents in early screening of colorectal cancer, so as to provide a scientific basis for optimizing the national screening program.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Single cohort of patients aged between 45 and 84, with no known high risk features, undergoing routine colorectal cancer screening as standard of care.
Key inclusion criteria (2 listed)
- Subjects aged 45-74 years at time of consent
- Have not had gastrointestinal resection
Key exclusion criteria (6 listed)
- Previous history of colorectal cancer
- Patients who have been confirmed to have other malignant neoplastic diseases of the digestive system
- Patients with severe heart, brain, lung disease or liver and kidney dysfunction or insufficiency
- Those with severe mental disorders and language communication disorders
- History of contraindications to colonoscopy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of colorectal cancer detection
Time frame: 180 days
Sensitivity of colorectal cancer detection
Specificity of advanced neoplasia detection
Time frame: 180 days
Specificity of advanced neoplasia detection
3 secondary outcomes
Positive predictive value of colorectal cancer detection
Time frame: 180 days
Negative predictive value of colorectal cancer detection
Time frame: 180 days
Sensitivity and specificity of advanced adenoma detection
Time frame: 180 days
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 21 Jan 2025.
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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.
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 The First Affiliated Hospital of Xinxiang Medical College 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 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: finished, as of the sponsor's last update on 21 Jan 2025. 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?
Sensitivity of colorectal cancer detection (time frame: 180 days). The study lists 2 primary outcomes in all. 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 21 Jan 2025.