Establishment of Big Data Platform and Biobank for Colorectal Tubular Adenoma Lesions

NCT06322225 | Not Yet Recruiting

• 1 other identifier: 2023YFC2507401
• Study Type: observational
• Target: 30,000
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• 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

  2024.05-2026.12

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

There were 30,000 patients diagnosed with colorectal tubular adenoma in our hospital and several research centers

You may qualify if:

• Voluntarily sign informed consent; Colorectal tubular adenoma was diagnosed according to JSGE clinical guidelines They are between 18 and 70 years old

You may not qualify if:

• 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

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University: lead
• National Key Research and Development Program of China: collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral venous blood, urine, stool and adenoma tissue will be collected

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 6, 2024
• First Posted: March 21, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 21, 2024

Record last verified: 2024-03