Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06200051
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-10
First Post:
2023-12-28
Brief Title:
Multi-cancer Joint Screening and Early Diagnosis and Treatment Project Based on the Combination of Chinese Traditional and Western Medicine in Lanxi City
Sponsor:
Lanxi Hospital of Traditional Chinese Medicine
Organization:
Lanxi Hospital of Traditional Chinese Medicine
Study Overview
Official Title:
Multi-cancer Joint Screening and Early Diagnosis and Treatment Project
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-12
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:
This study conducted a joint screening and early diagnosis and recommended treatment for LCA LC UGIC and CRC among residents aged 45 to 74 in six townships of Lanxi City Zhejiang Province Residents who voluntarily participated and signed informed consent forms completed cancer risk assessment questionnaires and traditional Chinese medicine spleen deficiency TCM-SD investigations The cancer risk assessment model established by the National Cancer Center was utilized to assess individual cancer risk scores Simultaneously blood samples three tubes one stool sample and one urine sample were collected from each participant Clinical screenings including low-dose spiral CT gastroscopy colonoscopy alpha-fetoprotein AFP and abdominal ultrasound were performed for individuals identified as high-risk through the assessment
Detailed Description:
Screening Methods Population Selection for Screening Utilizing a cluster sampling approach one-fifth of the residents from six townshipsdistricts were selected as the target population Villages communities were organized and mobilized as units to central screening points Work personnel were assigned to collaborate with local health institutions community health service centers to conduct a comprehensive survey of residents within their jurisdiction The target population was registered and documented and informed consent forms were obtained during this process
Assessment of High-Risk Population Utilizing a combination of questionnaire surveys and biological testing the target population underwent risk assessment to identify individuals at high risk requiring clinical screening Personnel administered the Cancer Risk Assessment Questionnaire 2022 edition and the Traditional Chinese Medicine Spleen Deficiency Questionnaire TCM-SDQ to residents for a comprehensive assessment of multi-cancer disease risk The questionnaire survey was conducted through face-to-face interviews by surveyors with data entered into the Lanxi Multi-Cancer Joint Screening data management platform Ensuring residents fully understood the questionnaire content maintaining the confidentiality of the survey and ensuring the authenticity of the information were essential during the investigation Additionally on-site testing for Hepatitis B surface antigen HBsAg fecal occult blood test FIT and Helicobacter pylori Hp was carried out Whole blood feces urine and other samples were collected on the same day for biological testing
Clinical Screening For individuals identified as high-risk for cancer by the risk assessment system they were informed of their cancer risk and organized to undergo specified clinical screenings at designated hospitals The clinical screenings included low-dose CT LDCT for the lungs upper gastrointestinal endoscopy with targeted indicated pathological biopsy colonoscopy with targeted indicated pathological biopsy AFP detection and liver ultrasound molybdenum target and ultrasound among others The screening protocols for the five common cancers lung upper gastrointestinal colorectal liver followed the Urban Cancer Screening and Early Diagnosis and Treatment Project Technical Plan 2022 edition Results from clinical screenings were systematically recorded in the Lanxi City Multicancer Integrated Screening data management platform
Population Follow-up For individuals identified as high-risk in the past and requiring follow-up notifications were sent through the information platform Project unit staff following the screening tasks collected information on the diagnosis and treatment of the follow-up subjects Follow-up activities were conducted actively and passively employing methods such as direct face-to-face visits telephone interviews self-administered questionnaires regular physical examinations environmental and disease monitoring and collection of attendance records from hospitals and workplaces The active follow-up targeted individuals with positive findings of various cancers detected through clinical examinations in the past specific criteria outlined in the Urban Cancer Screening Early Diagnosis and Treatment Project Follow-up Plan Active follow-up involved undergoing clinical examinations again and collecting follow-up information Among them those undergoing clinical examinations were included in the annual completion volume Follow-up information included detailed information on diagnosis and treatment For de-ceased individuals specific death information including time and cause of death etc needed to be obtained Passive follow-up involved matching the project participants with the local cancer registry and cause-of-death monitoring database to supplement information on cancer incidence and death among project participants
Assessment of High-Risk Population Utilizing a combination of questionnaire surveys and biological testing the target population underwent risk assessment to identify individuals at high risk requiring clinical screening Personnel administered the Cancer Risk Assessment Questionnaire 2022 edition and the Traditional Chinese Medicine Spleen Deficiency Questionnaire TCM-SDQ to residents for a comprehensive assessment of multi-cancer disease risk The questionnaire survey was conducted through face-to-face interviews by surveyors with data entered into the Lanxi Multi-Cancer Joint Screening data management platform Ensuring residents fully understood the questionnaire content maintaining the confidentiality of the survey and ensuring the authenticity of the information were essential during the investigation Additionally on-site testing for Hepatitis B surface antigen HBsAg fecal occult blood test FIT and Helicobacter pylori Hp was carried out Whole blood feces urine and other samples were collected on the same day for biological testing
Clinical Screening For individuals identified as high-risk for cancer by the risk assessment system they were informed of their cancer risk and organized to undergo specified clinical screenings at designated hospitals The clinical screenings included low-dose CT LDCT for the lungs upper gastrointestinal endoscopy with targeted indicated pathological biopsy colonoscopy with targeted indicated pathological biopsy AFP detection and liver ultrasound molybdenum target and ultrasound among others The screening protocols for the five common cancers lung upper gastrointestinal colorectal liver followed the Urban Cancer Screening and Early Diagnosis and Treatment Project Technical Plan 2022 edition Results from clinical screenings were systematically recorded in the Lanxi City Multicancer Integrated Screening data management platform
Population Follow-up For individuals identified as high-risk in the past and requiring follow-up notifications were sent through the information platform Project unit staff following the screening tasks collected information on the diagnosis and treatment of the follow-up subjects Follow-up activities were conducted actively and passively employing methods such as direct face-to-face visits telephone interviews self-administered questionnaires regular physical examinations environmental and disease monitoring and collection of attendance records from hospitals and workplaces The active follow-up targeted individuals with positive findings of various cancers detected through clinical examinations in the past specific criteria outlined in the Urban Cancer Screening Early Diagnosis and Treatment Project Follow-up Plan Active follow-up involved undergoing clinical examinations again and collecting follow-up information Among them those undergoing clinical examinations were included in the annual completion volume Follow-up information included detailed information on diagnosis and treatment For de-ceased individuals specific death information including time and cause of death etc needed to be obtained Passive follow-up involved matching the project participants with the local cancer registry and cause-of-death monitoring database to supplement information on cancer incidence and death among project participants
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