Gastrointestinal TumorsNCT07712107
A Study on Gastrointestinal Cancer Screening Using a Multi-Targeted Combined Detection Model
A study testing Multi-target blood methylation + fecal FIT + fecal calprotectin in people with Gastrointestinal Tumors, run by Xijing Hospital at 6 sites in China.
Trial summary
This study is a multicenter, randomized controlled trial. The plan is to enroll eligible participants and randomly assign them to two groups: one group will undergo testing using a combined model of "multi-target blood methylation + fecal FIT + fecal calpetin"; those with positive results will immediately undergo… Read more about this study
- Who is it for?
- Ages 45 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Tumors
- What is being tested?
- Multi-target blood methylation + fecal FIT + fecal calprotectin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10,000 participants
- Where
- 6 sitesChina
- Study dates
- 15 Jun 2026to 31 Dec 2035
- Phase
- Interventional
- 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 45 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants must be between 45 and 74 years of age at the time of enrollment;
- Participants must agree to be randomly assigned to different screening and follow-up strategies;
- Participants must agree to undergo a five-year follow-up in accordance with the protocol;
- Participants must be willing to participate and sign an informed consent form.
Who cannot join
- Underwent upper gastrointestinal endoscopy screening within the past year;
- History of any type of malignant tumor;
- Concurrent severe medical conditions that reduce the benefits of screening, such as severe pulmonary disease, kidney disease, liver disease, cardiovascular and cerebrovascular diseases, and hematological disorders;
- Other situations where a physician determines that endoscopic screening poses excessive risk (e.g., hemodynamic instability) or offers no benefit (e.g., short life expectancy);
- Pregnant or breastfeeding women.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
The 960th Hospital of the Joint Support Force of the People's Liberation Army of China
Jinan
jing Wang, +8615064115766, dolphinj228@hotmail.com
- Recruiting
Yanting County Tumor Hospital
Mianyang
Hu, +86 13778157819, 546331446@qq.com
- Recruiting
Wuwei Cancer Hospital of Gansu Province
Wuwei
linzhi Lu, +8613659359016, lulinzh12006@163.com
- Recruiting
Wuxi People's Hospital
Wuxi
fangmei An, +8613382241680, fangmeian@njmu.edu.cn
- Recruiting
Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province
Zhaoqing, Guangdong
Xianmiao Liu, +8618929838695, liuxianmiao@163.com
- Recruiting
Zhaoqing First People's Hospital, Guangdong Province
Zhaoqing
Jie Zhao, +8613760030296, 150398748@qq.com
About this study
Official title: A Study on Gastrointestinal Cancer Screening Using a Multi-Targeted Combined Detection Model: A Multi-center Prospective Randomized Controlled Trial
This study is a multicenter, randomized controlled trial. The plan is to enroll eligible participants and randomly assign them to two groups: one group will undergo testing using a combined model of "multi-target blood methylation + fecal FIT + fecal calpetin"; those with positive results will immediately undergo standard gastrointestinal endoscopy, while those with negative results will enter routine observation; the other group will undergo only routine observation and follow-up. All enrolled participants will undergo a 5-year prospective follow-up, during which information on gastrointestinal cancer incidence and mortality will be collected through regular contact and review of medical records. The primary endpoint of the study is the difference in 5-year all-gastrointestinal cancer mortality between the two groups.This project aims to use a randomized controlled trial design to evaluate whether an active screening strategy based on a combined model can effectively reduce the population-level mortality from gastrointestinal cancers compared to routine surveillance. The objective is to provide high-level evidence for establishing a new screening strategy that reduces the disease burden and delivers public health benefits. It lays the foundation for validating novel biomarkers and exploring the biological and behavioral factors that influence screening outcomes, and offers clear decision-making support for optimizing China's comprehensive prevention and control system for gastrointestinal cancers.
- Conditions
- Gastrointestinal Tumors
- Being tested
- Multi-target blood methylation + fecal FIT + fecal calprotectin
- 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.
Multi-target blood methylation + fecal FIT + fecal calprotectinDiagnostic test
The intervention group underwent testing using a combined model of "multi-target blood methylation + fecal FIT + fecal calprotectin"; those with positive results subsequently underwent standard gastrointestinal endoscopy, while those with negative results were placed under routine observation.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | Not described Receives: Diagnostic Test: Multi-target blood methylation + fecal FIT + fecal calprotectin |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in cancer-specific mortality rates across the entire gastrointestinal tract between the two groups.
Measured: Participants will be followed up for 5 years from the time of enrollment to collect data on gastrointestinal cancer-related deaths in both groups, with the final assessment of the primary outcome conducted at the 5-year mark after enrollment.
Secondary outcomes (5)
The incidence of gastrointestinal cancer in the two groups
Measured: Comparison of the incidence of new gastrointestinal cancers among the two groups of participants within five years of enrollment
Sensitivity and specificity of the combined screening model for detecting gastrointestinal cancers in the intervention group
Measured: Baseline
All-cause mortality in the two groups
Measured: All-cause mortality among all participants within 5 years of enrollment
Detection rate of precancerous lesions and early-stage gastrointestinal tumors
Measured: At baseline and during foDetection of early-stage lesions llow-up within 5 years of enrollment
Incidence of endoscopy-related complications
Measured: Incidence of various endoscopy-related complications observed within 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2026
- Study start15 Jun 2026
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2035 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07712107
- Sponsor's protocol ID
- KY20262032-C-1
- Status last verified
- Jan 2026
- First submitted
- 13 Jul 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Applications shall be submitted to the principal investigator upon study completion. Applicants are required to provide a data analysis plan, and data sharing will be approved after assessment.
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Gastrointestinal Cancer Screening Using a Multi-Targeted Combined Detection Model: A Multi-center Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07712107
- Acronym / sponsor ID
- KY20262032-C-1
- Conditions
- Gastrointestinal Tumors
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 15 Jun 2026 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 17 Jul 2026 (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 is a multicenter, randomized controlled trial. The plan is to enroll eligible participants and randomly assign them to two groups: one group will undergo testing using a combined model of "multi-target blood methylation + fecal FIT + fecal calpetin"; those with positive results will immediately undergo standard gastrointestinal endoscopy, while those with negative results will enter routine observation; the other group will undergo only routine observation and follow-up. All enrolled participants will undergo a 5-year prospective follow-up, during which information on gastrointestinal cancer incidence and mortality will be collected through regular contact and review of medical records. The primary endpoint of the study is the difference in 5-year all-gastrointestinal cancer mortality between the two groups.This project aims to use a randomized controlled trial design to evaluate whether an active screening strategy based on a combined model can effectively reduce the population-level mortality from gastrointestinal cancers compared to routine surveillance. The objective is to provide high-level evidence for establishing a new screening strategy that reduces the disease burden and delivers public health benefits. It lays the foundation for validating novel biomarkers and exploring the biological and behavioral factors that influence screening outcomes, and offers clear decision-making support for optimizing China's comprehensive prevention and control system for gastrointestinal cancers.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Diagnostic Test: Multi-target blood methylation + fecal FIT + fecal calprotectin |
| control group | No intervention | – |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participants must be between 45 and 74 years of age at the time of enrollment;
- Participants must agree to be randomly assigned to different screening and follow-up strategies;
- Participants must agree to undergo a five-year follow-up in accordance with the protocol;
- Participants must be willing to participate and sign an informed consent form.
Key exclusion criteria (5 listed)
- Underwent upper gastrointestinal endoscopy screening within the past year;
- History of any type of malignant tumor;
- Concurrent severe medical conditions that reduce the benefits of screening, such as severe pulmonary disease, kidney disease, liver disease, cardiovascular and cerebrovascular diseases, and hematological disorders;
- Other situations where a physician determines that endoscopic screening poses excessive risk (e.g., hemodynamic instability) or offers no benefit (e.g., short life expectancy);
- Pregnant or breastfeeding women.
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 |
|---|---|---|
| Multi-target blood methylation + fecal FIT + fecal calprotectinThe intervention group underwent testing using a combined model of "multi-target blood methylation + fecal FIT + fecal calprotectin"; those with positive results subsequently underwent standard gastrointestinal endoscopy, while those with negative results were placed under routine observation. | Diagnostic test | Intervention group |
Primary outcome
Differences in cancer-specific mortality rates across the entire gastrointestinal tract between the two groups.
Time frame: Participants will be followed up for 5 years from the time of enrollment to collect data on gastrointestinal cancer-related deaths in both groups, with the final assessment of the primary outcome conducted at the 5-year mark after enrollment.
5 secondary outcomes
The incidence of gastrointestinal cancer in the two groups
Time frame: Comparison of the incidence of new gastrointestinal cancers among the two groups of participants within five years of enrollment
Sensitivity and specificity of the combined screening model for detecting gastrointestinal cancers in the intervention group
Time frame: Baseline
All-cause mortality in the two groups
Time frame: All-cause mortality among all participants within 5 years of enrollment
Detection rate of precancerous lesions and early-stage gastrointestinal tumors
Time frame: At baseline and during foDetection of early-stage lesions llow-up within 5 years of enrollment
Incidence of endoscopy-related complications
Time frame: Incidence of various endoscopy-related complications observed within 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 14 Aug 2026.
- Individual participant dataSharing planned: Yes. Applications shall be submitted to the principal investigator upon study completion. Applicants are required to provide a data analysis plan, and data sharing will be approved after assessment.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-target blood methylation + fecal FIT + fecal calprotectin in people with Gastrointestinal Tumors, run by Xijing Hospital at 6 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 4 inclusion and 5 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 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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 Yongzhan Nie (+86 198 2975 8242, zhengrong4956@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in cancer-specific mortality rates across the entire gastrointestinal tract between the two groups. (time frame: Participants will be followed up for 5 years from the time of enrollment to collect data on gastrointestinal cancer-related deaths in both groups, with the final assessment of the primary outcome conducted at the 5-year mark after enrollment.). 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 14 Aug 2026.