Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT06200051 |
| Other study ID # |
LX2023 |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
May 12, 2023 |
| Est. completion date |
December 2026 |
Study information
| Verified date |
December 2023 |
| Source |
Lanxi Hospital of Traditional Chinese Medicine |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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.
Description:
Screening Methods Population Selection for Screening: Utilizing a cluster sampling approach,
one-fifth of the residents from six townships/districts 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.
