Ignite Creation Date:
2024-07-17 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06478030
Status:
RECRUITING
Last Update Posted:
2024-06-27
First Post:
2024-06-21
Brief Title:
Combined Screening for Gastrointestinal Tumors
Sponsor:
Zhejiang Cancer Hospital
Organization:
Zhejiang Cancer Hospital
Study Overview
Official Title:
Combined Screening for Gastrointestinal Tumors
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
All participants are required to complete a questionnaire a Helicobacter pylori H pylori test and a fecal immunochemical test FIT The questionnaire covers nine aspects basic information of the participants symptoms and previous examinations medical history and surgical history medication history smoking history alcohol consumption history dietary habits physical exercise and family history After quality control the data is entered by staff into the Zhejiang Province Cancer Screening Information Platform Combining the results of the Helicobacter pylori test and the fecal immunochemical test the system identifies high-risk individuals who need clinical screening Additionally stool urine blood tongue coating saliva tongue appearance gastric juice and fresh tissue gastric mucosa tissue andor intestinal polyp tissue samples are collected from all participants undergoing clinical screening
Participants are required to complete at least one passive follow-up annually Active follow-ups are conducted for those with positive screening results to ensure timely completion of endoscopic examinations For those who have not undergone endoscopic examinations despite positive screening results health education is provided and they are mobilized to complete at least four endoscopic examinations within one month For participants diagnosed and treated for precancerous lesions and tumors diagnostic and treatment data must be collected and they are encouraged to follow up as per medical advice Both active and passive follow-up results must be recorded in the screening follow-up information record form and reported to the Zhejiang Province Cancer Screening Information Platform
This is a government collaboration project All subjects will also be followed by record linkage to Cancer Register and Population Register
Participants are required to complete at least one passive follow-up annually Active follow-ups are conducted for those with positive screening results to ensure timely completion of endoscopic examinations For those who have not undergone endoscopic examinations despite positive screening results health education is provided and they are mobilized to complete at least four endoscopic examinations within one month For participants diagnosed and treated for precancerous lesions and tumors diagnostic and treatment data must be collected and they are encouraged to follow up as per medical advice Both active and passive follow-up results must be recorded in the screening follow-up information record form and reported to the Zhejiang Province Cancer Screening Information Platform
This is a government collaboration project All subjects will also be followed by record linkage to Cancer Register and Population Register
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None