Gastrointestinal TumorsNCT06478030
Combined Screening for Gastrointestinal Tumors
An observational study of Gastrointestinal Tumors, run by Zhejiang Cancer Hospital at 2 sites in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Gastrointestinal Tumors
- What is being tested?
- questionnaire, Helicobacter pylori (H. pylori) test, fecal immunochemical test (FIT)
- How many people
- 200,000 participants
- Where
- 2 sitesChina
- Study dates
- 1 Mar 2023to 31 Dec 2028
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Population data obtained from local government departments is used to identify eligible participants. From this pool, individuals who meet the criteria are selected, and their names along with basic information are recorded.
Who may be able to join
- Subject residents from Zhejiang Province.
- Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
- Subject has psychical condition and well consciousness, and also accept and cooperate with the follow-up of this study.
Who cannot join
- Subject has heavy cardiovascular, liver or kidney disease.
- Subject is already suffering from malignant tumors of the digestive tract.
- Subject has severe intellectual disabilities or language communication barriers.
- Subject has had gastrointestinal endoscopy in the past year.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Yongkang City
Jinhua, Zhejiang, 321300
Lingbin Du, +86-13588114180, dulb@zjcc.org.cn
- Recruiting
Fenghua District
Ningbo, Zhejiang, 315500
Xiangdong Cheng, MD, 13968032995, chengxd@zjcc.org.cn
About this study
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. Risk assessments are performed based on the data collected and high-risk individuals are recommended for clinical screening. Additionally, tongue image, stool, urine, blood, tongue coating, saliva, gastric juice, and fresh tissue (gastric mucosa tissue and/or 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 at least four times within one month to complete endoscopic examinations. 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.
- Conditions
- Gastrointestinal Tumors
- Being tested
- questionnaire, Helicobacter pylori (H. pylori) test, fecal immunochemical test (FIT)
- Medical subject headings
- Digestive System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
questionnaire, Helicobacter pylori (H. pylori) test, fecal immunochemical test (FIT)Diagnostic test
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.
| Study group | Role | What they receive |
|---|---|---|
| Screening cohort | Healthy participants aged 40-74 years from designated communities. Receives: Diagnostic Test: questionnaire, Helicobacter pylori (H. pylori) test, fecal immunochemical test (FIT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal cancers detection, incidence and mortality
Gastrointestinal cancers detection through endoscopies, and gastrointestinal cancers incidence and mortality with long-term follow-up.
Measured: 5 years
Secondary outcomes (1)
Early diagnosis of gastrointestinal cancers
Early diagnosis of gastrointestinal cancers using different strategies.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2024
- Study start1 Mar 2023
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal TumorsStudies of the same condition, open and under way.
- More trials run by Zhejiang Cancer HospitalThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 200,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Zhejiang Cancer Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fenghua District People's Hospital, Ningbo City, Fenghua District Traditional Chinese Medicine Hospital, Ningbo City, Xikou Hospital in Fenghua District, Ningbo City, Yongkang Traditional Chinese Medicine Hospital, Hangzhou Medical College
- Responsible party
- Principal investigator, Xiangdong Cheng, Zhejiang Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06478030
- Sponsor's protocol ID
- IRB-2023-890
- Status last verified
- Jan 2025
- First submitted
- 21 Jun 2024
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Not provided
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Screening for Gastrointestinal Tumors
- ClinicalTrials.gov ID
- NCT06478030
- Acronym / sponsor ID
- IRB-2023-890
- Conditions
- Gastrointestinal Tumors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200,000 participants (estimated)
- Lead sponsor
- Zhejiang Cancer HospitalUniversity, hospital or other
- Collaborators
- Fenghua District People's Hospital, Ningbo City, Fenghua District Traditional Chinese Medicine Hospital, Ningbo City, Xikou Hospital in Fenghua District, Ningbo City, Yongkang Traditional Chinese Medicine Hospital, Hangzhou Medical College
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 27 Jun 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.
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. Risk assessments are performed based on the data collected and high-risk individuals are recommended for clinical screening. Additionally, tongue image, stool, urine, blood, tongue coating, saliva, gastric juice, and fresh tissue (gastric mucosa tissue and/or 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 at least four times within one month to complete endoscopic examinations. 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Screening cohort | – | Diagnostic Test: questionnaire, Helicobacter pylori (H. pylori) test, fecal immunochemical test (FIT)Healthy participants aged 40-74 years from designated communities. |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population data obtained from local government departments is used to identify eligible participants. From this pool, individuals who meet the criteria are selected, and their names along with basic information are recorded.
Key inclusion criteria (3 listed)
- Subject residents from Zhejiang Province.
- Subject is able to comprehend, sign, and date the written informed consent document to participate in the study.
- Subject has psychical condition and well consciousness, and also accept and cooperate with the follow-up of this study.
Key exclusion criteria (4 listed)
- Subject has heavy cardiovascular, liver or kidney disease.
- Subject is already suffering from malignant tumors of the digestive tract.
- Subject has severe intellectual disabilities or language communication barriers.
- Subject has had gastrointestinal endoscopy in the past year.
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 |
|---|---|---|
| questionnaire, Helicobacter pylori (H. pylori) test, 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. | Diagnostic test | Screening cohort |
Primary outcome
Gastrointestinal cancers detection, incidence and mortality
Time frame: 5 years
Gastrointestinal cancers detection through endoscopies, and gastrointestinal cancers incidence and mortality with long-term follow-up.
1 secondary outcome
Early diagnosis of gastrointestinal cancers
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No. Not provided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Tumors, run by Zhejiang Cancer Hospital at 2 sites 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 3 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiangdong Cheng, MD (13968032995, chengxd@zjcc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastrointestinal cancers detection, incidence and mortality (time frame: 5 years). 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 Jan 2025.