Colorectal Tubular AdenomaNCT06322225
Establishment of Big Data Platform and Biobank for Colorectal Tubular Adenoma Lesions
An observational study of Colorectal Tubular Adenoma, run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
Colorectal tubular adenoma is the most common precancerous lesion of colorectal cancer, and the point is that its precise prevention and treatment can reduce the incidence of colorectal cancer.However, the epidemiological characteristics of colorectal tubular adenoma in China are unclear, the rate of missed diagnosis… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Colorectal Tubular Adenoma
- How many people
- 30,000 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: There were 30,000 patients diagnosed with colorectal tubular adenoma in our hospital and several research centers
Who may be able to join
- Voluntarily sign informed consent; Colorectal tubular adenoma was diagnosed according to JSGE clinical guidelines They are between 18 and 70 years old
Who cannot join
- Refuse to sign the informed consent Patients who were judged by the investigator to be unsuitable for participation in this study.
- The diagnosis is not tubular adenoma of colorectal or other adenomas according to JSGE clinical guidelines Age < 18 or > 70
About this study
Official title: Construction and Demonstration of Accurate Prevention and Treatment System for Colorectal Tubular Adenoma
Colorectal tubular adenoma is the most common precancerous lesion of colorectal cancer, and the point is that its precise prevention and treatment can reduce the incidence of colorectal cancer.However, the epidemiological characteristics of colorectal tubular adenoma in China are unclear, the rate of missed diagnosis by colonoscopy is high, and the existing diagnosis and treatment techniques are lack of unified quality control standards,which makes it difficult to diagnose and achieve accurate prevention and control. How to improve the precise prevention and treatment of colorectal tubular adenoma and reduce the incidence of colorectal cancer is a major clinical scientific problem that needs to be solved urgently. For this purpose, this study was conducted in colorectal guided by the needs of accurate prevention and treatment of tubular adenoma lesions,and a multi-center colorectal tubular adenoma data management platform and a high-risk population database covering a full range of data including demographic characteristics, lifestyle factors, clinical information, endoscopic data and pathological images were established, biological sample databases of patients with pathological changes and high-risk populations were established, and data quality control and sample quality control standards were formulated standards-based.
The pathological prediction model and accurate risk assessment system of colorectal tubular adenoma were constructed by the pathological database.
- Conditions
- Colorectal Tubular Adenoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical information such as demographic characteristics, clinical data, endoscopy and pathological images
Through the collection of clinical data and biological samples, we established a tubular adenoma big data platform and biobank, and established a precision prevention and treatment system for tubular adenoma
Measured: 2024.05-2026.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2024
- Study start1 May 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal Tubular AdenomaStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Key Research and Development Program of China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06322225
- Sponsor's protocol ID
- 2023YFC2507401
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 21 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Construction and Demonstration of Accurate Prevention and Treatment System for Colorectal Tubular Adenoma
- ClinicalTrials.gov ID
- NCT06322225
- Acronym / sponsor ID
- 2023YFC2507401
- Conditions
- Colorectal Tubular Adenoma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- National Key Research and Development Program of China
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Mar 2024 (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 tubular adenoma is the most common precancerous lesion of colorectal cancer, and the point is that its precise prevention and treatment can reduce the incidence of colorectal cancer.However, the epidemiological characteristics of colorectal tubular adenoma in China are unclear, the rate of missed diagnosis by colonoscopy is high, and the existing diagnosis and treatment techniques are lack of unified quality control standards,which makes it difficult to diagnose and achieve accurate prevention and control. How to improve the precise prevention and treatment of colorectal tubular adenoma and reduce the incidence of colorectal cancer is a major clinical scientific problem that needs to be solved urgently. For this purpose, this study was conducted in colorectal guided by the needs of accurate prevention and treatment of tubular adenoma lesions,and a multi-center colorectal tubular adenoma data management platform and a high-risk population database covering a full range of data including demographic characteristics, lifestyle factors, clinical information, endoscopic data and pathological images were established, biological sample databases of patients with pathological changes and high-risk populations were established, and data quality control and sample quality control standards were formulated standards-based.
The pathological prediction model and accurate risk assessment system of colorectal tubular adenoma were constructed by the pathological database.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- There were 30,000 patients diagnosed with colorectal tubular adenoma in our hospital and several research centers
Key inclusion criteria (1 listed)
- Voluntarily sign informed consent; Colorectal tubular adenoma was diagnosed according to JSGE clinical guidelines They are between 18 and 70 years old
Key exclusion criteria (2 listed)
- Refuse to sign the informed consent Patients who were judged by the investigator to be unsuitable for participation in this study.
- The diagnosis is not tubular adenoma of colorectal or other adenomas according to JSGE clinical guidelines Age < 18 or > 70
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
Clinical information such as demographic characteristics, clinical data, endoscopy and pathological images
Time frame: 2024.05-2026.12
Through the collection of clinical data and biological samples, we established a tubular adenoma big data platform and biobank, and established a precision prevention and treatment system for tubular adenoma
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Colorectal Tubular Adenoma, run by Sixth Affiliated Hospital, Sun Yat-sen 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 1 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: opening soon, as of the sponsor's last update on 21 Mar 2024. 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. 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?
This study is still under way. Results are not available in the source record yet.
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?
Clinical information such as demographic characteristics, clinical data, endoscopy and pathological images (time frame: 2024.05-2026.12). 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 Mar 2024.