Cancer ScreeningNCT06200051
Multi-cancer Joint Screening and Early Diagnosis and Treatment Project Based on the Combination of Chinese Traditional and Western Medicine in Lanxi City
An observational study of Cancer Screening, run by Lanxi Hospital of Traditional Chinese Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 45 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer Screening
- What is being tested?
- Prediction of high risk of cancer
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 12 May 2023to 5 May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multi-cancer Joint Screening and Early Diagnosis and Treatment Project
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.
Read the detailed 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.
- Conditions
- Cancer Screening
- Being tested
- Prediction of high risk of cancer
- Keywords
- cancer screeing, traditional chinese medicine, risk, Lanxi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prediction of high risk of cancerDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| High-risk group | Not described Receives: Diagnostic Test: Prediction of high risk of cancer | |
| Moderate-risk group | Not described Receives: Diagnostic Test: Prediction of high risk of cancer | |
| Low-risk group | Not described Receives: Diagnostic Test: Prediction of high risk of cancer |
What is being measured
The primary outcome is the main question the study is designed to answer.
program coverage rate
percentage of people guided by navigators
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 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%.
Measured: 2024.01-2026.12
Secondary outcomes (4)
Risk factor investigation
According to the findings of CRAQ and TCM-SDQ, the risk factors were investigated, including dietary habits, living environment, lifestyle, medical history, family history of malignancies, past medication history, female physiology, reproductive history, and pri-marily TCM-SD symptoms
Measured: 2024.01-2026.12
Awareness rate of cancer prevention and treatment among residents
To objectively assess the level of cancer prevention and control knowledge among resi-conduct a survey based on the Cancer Prevention and Con-trol Core Knowledge Awareness Survey Scale released by the NCC.
Measured: 2024.01-2026.12
Cost effectiveness analysis
In order to estimate the cost-effectiveness of the implementation of such a program, mar-ginal costs, with encryption on the actual cost, observed during the installation, as well as a projection on a routine cost will be taken into account.
Measured: 2024.01-2026.12
5-year cancer survival rate
We will employ a combination of proactive and passive follow-ups, along with linkage to the city's population database and mortality database, to calculate the five-year survival rates for patients with four types of cancer.
Measured: 2024.01-2029.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2024
- Study start12 May 2023
- Primary completion5 Mar 2024
- Study completion5 May 2024
Why it stopped: No participants enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lanxi Hospital of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Zhejiang Chinese Medical University, Zhejiang Cancer Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06200051
- Sponsor's protocol ID
- LX2023
- Status last verified
- Jul 2025
- First submitted
- 28 Dec 2023
- Last updated
- 28 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-cancer Joint Screening and Early Diagnosis and Treatment Project
- ClinicalTrials.gov ID
- NCT06200051
- Acronym / sponsor ID
- LX2023
- Conditions
- Cancer Screening
- Keywords
- cancer screeing, traditional chinese medicine, risk, Lanxi
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: No participants enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lanxi Hospital of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Zhejiang Chinese Medical University, Zhejiang Cancer Hospital
- Study start
- 12 May 2023 (actual)
- Primary completion
- 5 Mar 2024 (actual)
- Study completion
- 5 May 2024 (actual)
- First posted
- 10 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prediction of high risk of cancerThis 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. | Diagnostic test | High-risk group, Low-risk group, Moderate-risk group |
Primary outcome
program coverage rate
Time frame: 2024.01-2026.12
percentage of people guided by navigators
screening participation rate
Time frame: 2024.01-2026.12
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%.
high-risk rate
Time frame: 2024.01-2026.12
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%.
Positive lesion detection rate
Time frame: 2024.01-2026.12
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%.
Detection rate
Time frame: 2024.01-2026.12
Detection rate is computed as the number of confirmed cancer cases divided by the total number of screened cases, multiplied by 100%.
4 secondary outcomes
Risk factor investigation
Time frame: 2024.01-2026.12
Awareness rate of cancer prevention and treatment among residents
Time frame: 2024.01-2026.12
Cost effectiveness analysis
Time frame: 2024.01-2026.12
5-year cancer survival rate
Time frame: 2024.01-2029.12
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Screening, run by Lanxi Hospital of Traditional Chinese Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
program coverage rate (time frame: 2024.01-2026.12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2025.