Gastrointestinal CancersNCT07769892
A Multicenter Prospective Observational Cohort Study for Digestive Tract Tumor Screening Using Multi-Target Blood and Fecal Biomarkers
An observational study of Gastrointestinal Cancers, run by Xijing Hospital at 7 sites in China.
Trial summary
This project aims to evaluate the sensitivity and specificity of combined blood multi-gene methylation and fecal biomarkers for pan-digestive tract cancer screening, so as to establish a novel technical system for the early diagnosis of pan-digestive tract cancers.Individuals scheduled to receive digestive tract… Read more about this study
- Who is it for?
- Ages 45 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Cancers
- How many people
- 5,000 participants
- Where
- 7 sitesChina
- Study dates
- 10 Aug 2026to 31 Dec 2035
- 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 45 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eligible subjects shall be aged 45 to 74 years at enrollment, scheduled to receive digestive tract endoscopic screening, willing to complete five-year follow-up as specified by the protocol, and capable of signing the informed consent form.
Who may be able to join
- 1.Subjects aged 45-74 years at enrollment; 2.Scheduled to undergo digestive tract endoscopic screening; 3.Agree to receive five-year follow-up in accordance with the study protocol; 4.Willing to provide written informed consent.
Who cannot join
- 1. Having received upper gastrointestinal endoscopy within one year; 2.History of any type of malignant tumor; 3.Complicated with severe illnesses that reduce screening benefits, such as severe pulmonary, renal, hepatic, cardiovascular, cerebrovascular and hematological diseases; 4.Other conditions assessed by physicians as excessively high risk for endoscopic screening (e.g., hemodynamic instability) or non-beneficial (short life expectancy); 5.Pregnant or lactating women.
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
China7 sites, 7 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
he Hu, +8613778157819, 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
The First Affiliated Hospital of Air Force Military Medical University
Xi'an, Shaanxi, 710032
Yongzhan Nie, +86 198 2975 8242, zhengrong4956@163.com
- 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 Multicenter Prospective Observational Cohort Study on Digestive Tract Tumor Screening Based on Combined Detection of Multi-Target Blood and Fecal Biomarkers
This project aims to evaluate the sensitivity and specificity of combined blood multi-gene methylation and fecal biomarkers for pan-digestive tract cancer screening, so as to establish a novel technical system for the early diagnosis of pan-digestive tract cancers.Individuals scheduled to receive digestive tract endoscopy are enrolled. Blood and stool samples are collected prior to endoscopic examination for detection of blood multi-gene methylation, fecal immunochemical test (FIT) and calprotectin. Endoscopic procedures are then performed. Following completion of baseline endoscopic screening, all enrolled participants will be followed up for 5 years. The primary endpoint of this study is the sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers in screening for pan-digestive tract cancers.
- Conditions
- Gastrointestinal Cancers
- Medical subject headings
- Gastrointestinal Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity of blood multi-gene methylation combined with fecal biomarkers for pan-digestive tract cancer screening, with endoscopy plus pathological biopsy serving as the gold standard
Measured: Day 1 At endoscopy and pathological confirmation after enrollment
Specificity of combined biomarkers for pan-digestive tract cancer screening
Measured: Day 1 At endoscopy and pathological confirmation after enrollment
Secondary outcomes (8)
Detection rate of precancerous lesions of digestive tract by blood multi-gene methylation combined with fecal biomarkers.
Measured: 5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for esophageal cancer screening
Measured: 5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for gastric cancer screening
Measured: 5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for colorectal cancer screening
Measured: 5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers in screening for high-grade intraepithelial neoplasia of esophageal mucosa and early esophageal cancer
Measured: 5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for screening high-grade gastric mucosal intraepithelial neoplasia and early gastric cancer
Measured: 5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for screening high-grade colorectal mucosal intraepithelial neoplasia and early colorectal cancer
Measured: 5 years after enrollment
Complications from endoscopic screening mainly include potential bleeding, perforation, infection, cardiovascular and cerebrovascular adverse events, aspiration, and screening-related mortality.
Measured: 5 years after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start10 Aug 2026 (estimated)
- 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 CancersStudies 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
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yongzhan Nie, Principal investigator, Xijing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07769892
- Sponsor's protocol ID
- KY20262029-C-1
- Status last verified
- Jun 2026
- First submitted
- 13 Jul 2026
- Last updated
- 18 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 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Observational Cohort Study on Digestive Tract Tumor Screening Based on Combined Detection of Multi-Target Blood and Fecal Biomarkers
- ClinicalTrials.gov ID
- NCT07769892
- Acronym / sponsor ID
- KY20262029-C-1
- Conditions
- Gastrointestinal Cancers
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Xijing HospitalUniversity, hospital or other
- Study start
- 10 Aug 2026 (estimated)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2035 (estimated)
- First posted
- 18 Aug 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 project aims to evaluate the sensitivity and specificity of combined blood multi-gene methylation and fecal biomarkers for pan-digestive tract cancer screening, so as to establish a novel technical system for the early diagnosis of pan-digestive tract cancers.Individuals scheduled to receive digestive tract endoscopy are enrolled. Blood and stool samples are collected prior to endoscopic examination for detection of blood multi-gene methylation, fecal immunochemical test (FIT) and calprotectin. Endoscopic procedures are then performed. Following completion of baseline endoscopic screening, all enrolled participants will be followed up for 5 years. The primary endpoint of this study is the sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers in screening for pan-digestive tract cancers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible subjects shall be aged 45 to 74 years at enrollment, scheduled to receive digestive tract endoscopic screening, willing to complete five-year follow-up as specified by the protocol, and capable of signing the informed consent form.
Key inclusion criteria (1 listed)
- 1.Subjects aged 45-74 years at enrollment; 2.Scheduled to undergo digestive tract endoscopic screening; 3.Agree to receive five-year follow-up in accordance with the study protocol; 4.Willing to provide written informed consent.
Key exclusion criteria (1 listed)
- 1. Having received upper gastrointestinal endoscopy within one year; 2.History of any type of malignant tumor; 3.Complicated with severe illnesses that reduce screening benefits, such as severe pulmonary, renal, hepatic, cardiovascular, cerebrovascular and hematological diseases; 4.Other conditions assessed by physicians as excessively high risk for endoscopic screening (e.g., hemodynamic instability) or non-beneficial (short life expectancy); 5.Pregnant or lactating women.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Sensitivity of blood multi-gene methylation combined with fecal biomarkers for pan-digestive tract cancer screening, with endoscopy plus pathological biopsy serving as the gold standard
Time frame: Day 1 At endoscopy and pathological confirmation after enrollment
Specificity of combined biomarkers for pan-digestive tract cancer screening
Time frame: Day 1 At endoscopy and pathological confirmation after enrollment
8 secondary outcomes
Detection rate of precancerous lesions of digestive tract by blood multi-gene methylation combined with fecal biomarkers.
Time frame: 5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for esophageal cancer screening
Time frame: 5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for gastric cancer screening
Time frame: 5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for colorectal cancer screening
Time frame: 5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers in screening for high-grade intraepithelial neoplasia of esophageal mucosa and early esophageal cancer
Time frame: 5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for screening high-grade gastric mucosal intraepithelial neoplasia and early gastric cancer
Time frame: 5 years after enrollment
Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for screening high-grade colorectal mucosal intraepithelial neoplasia and early colorectal cancer
Time frame: 5 years after enrollment
Complications from endoscopic screening mainly include potential bleeding, perforation, infection, cardiovascular and cerebrovascular adverse events, aspiration, and screening-related mortality.
Time frame: 5 years after enrollment
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 18 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.
Yongzhan Nie principal investigator
Xijing Hospital
7 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 Cancers, run by Xijing Hospital at 7 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 1 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: looking for participants now, as of the sponsor's last update on 18 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 7 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 Rong Zheng (+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?
Sensitivity of blood multi-gene methylation combined with fecal biomarkers for pan-digestive tract cancer screening, with endoscopy plus pathological biopsy serving as the gold standard (time frame: Day 1 At endoscopy and pathological confirmation after enrollment). The study lists 2 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 18 Aug 2026.