Multi-cancer Joint Screening and Early Diagnosis and Treatment Project Based on the Combination of Chinese Traditional and Western Medicine in Lanxi City

NCT06200051 | Withdrawn

• 1 other identifier: LX2023
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer Screening

Keywords

cancer screeing; traditional chinese medicine; risk; Lanxi

Outcome Measures

Primary Outcomes (5)

• program coverage rate

  percentage of people guided by navigators

  2024.01-2026.12

• screening participation rate

  Screening participation rate (%) is determined by the number of clinical screening cases divided by the number of cases identified as high-risk, multiplied by 100%.

  2024.01-2026.12

• high-risk rate

  The high-risk rate (%) is calculated as the high-risk individuals identified divided by the total number of participants in the assessment, multiplied by 100%.

  2024.01-2026.12

• Positive lesion detection rate

  Positive lesion detection rate is calculated as the number of clinically detected positive lesions divided by the total number of screened cases, multiplied by 100%.

  2024.01-2026.12

• Detection rate

  Detection rate is computed as the number of confirmed cancer cases divided by the total number of screened cases, multiplied by 100%.

  2024.01-2026.12

Secondary Outcomes (4)

• Risk factor investigation

  2024.01-2026.12

• Awareness rate of cancer prevention and treatment among residents

  2024.01-2026.12

• Cost effectiveness analysis

  2024.01-2026.12

• 5-year cancer survival rate

  2024.01-2029.12

Study Arms (3)

High-risk group

Diagnostic Test: Prediction of high risk of cancer

Moderate-risk group

Diagnostic Test: Prediction of high risk of cancer

Low-risk group

Diagnostic Test: Prediction of high risk of cancer

Interventions

Prediction of high risk of cancer DIAGNOSTIC_TEST

This initiative is aimed at comprehending the incidence rates of these four types of cancers, including lung cancer (LCA), liver cancer (LC), upper gastrointestinal cancer (UGIC), and CRC, to provide a theoretical foundation for the implementation of more practical and effective cancer screening strategies.

High-risk group; Low-risk group; Moderate-risk group

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Utilizing a cluster sampling approach, one-fifth of the residents from six town-ships/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.

You may qualify if:

• The survey focused on residents aged 45 to 74 years, based on their permanent residency status (The date of birth on the ID card shall prevail).
• All participants possessed full legal capacity and voluntarily signed informed consent forms.

You may not qualify if:

• Individuals who had moved out, long-term absence, or had household separation were excluded. The screening participants were further confirmed to meet the eligibility criteria after excluding those with poor compliance, already diagnosed with tumors, or having severe heart, brain, lung diseases, or renal dysfunction.

Sponsors & Collaborators

• Lanxi Hospital of Traditional Chinese Medicine: lead
• Zhejiang Chinese Medical University: collaborator
• Zhejiang Cancer Hospital: collaborator

Study Sites (1)

Jing Xiao

Lanxi, Zhejiang, 321100, China

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2023
• First Posted: January 10, 2024
• Study Start: May 12, 2023
• Primary Completion: March 5, 2024
• Study Completion: May 5, 2024
• Last Updated: July 28, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)