Gastric Cancer, Colorectal CancerNCT07600125
Evaluation of Fecal Multi-target Biomarkers in the Screening of Digestive Tract Cancers
An observational study of Gastric Cancer, Colorectal Cancer, run by Xijing Hospital at 13 sites in China.
Trial summary
This study is a multi-center, observational study. Participants scheduled for gastroscopy and colonoscopy will undergo an epidemiological assessment and provide a stool sample prior to endoscopy for qualitative Fecal Immunochemical Test (FIT), quantitative Fecal Immunochemical Test (FIT), and novel biomarker testing… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastric Cancer, Colorectal Cancer
- What is being tested?
- Qualitative Fecal Immunochemical Test (FIT), quantitative (FIT), and testing for new biomarkers
- How many people
- 5,000 participants
- Where
- 13 sitesChina
- Study dates
- 10 Aug 2026to 31 Dec 2027
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study will enroll individuals aged 18 and older who are scheduled to undergo gastrointestinal endoscopy and are willing to participate in the screening.
Who may be able to join
- Participants must be at least 18 years of age at the time of enrollment;
- Participants must be scheduled to undergo gastroscopy and colonoscopy;
- Participants must agree to undergo a two-year follow-up as outlined in the protocol;
- Participants must be willing to participate and sign an informed consent form.
Who cannot join
- Have undergone gastrointestinal endoscopy screening within the past year;
- History of any type of gastrointestinal malignancy;
- 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
13 sites in 1 country. Contact the study team or a site near you to ask about taking part.
13 sites in 1 country
China13 sites, 13 recruiting
- Recruiting
The First Affiliated Hospital of Dalian Medical University
Dalian
shibin Guo, +8618098875559, guoshibin@firsthosp-dmu.com
- Recruiting
Hongxing Hospital of the 13th Division, Xinjiang Production and Construction Corps
Hami
lina Ye, +8618196905033, 69426995@qq.com
- Recruiting
Cao County People's Hospital
Heze
yongfang Liu, +8617660319321, lyf881013@163.com
- 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
PetroChina Central Hospital, Hebei
Langfang
cuiling Xu, +8615933160598, 452285334@qq.com
- Recruiting
Huoqiu County People's Hospital
Liu‘an
meng Xie, +8613084047251, 779754451@qq.com
- Recruiting
Qingdao Municipal Hospital
Qingdao
wenli Li, +8618562652793, lwl201@163.com
- Recruiting
Central Theater Command General Hospital
Wuhan
Xu, +8618163545237, xuwt0219@163.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
Zheng, +86 198 2975 8242, zhengrong4956@163.com
- Recruiting
Gaoyao District People's Hospital, Zhaoqing City, Guangdong Province
Zhaoqing
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: Evaluation of Fecal Multi-target Biomarkers in the Screening of Digestive Tract Cancers: a Multi-center Prospective Observational Cohort Study
This study is a multi-center, observational study. Participants scheduled for gastroscopy and colonoscopy will undergo an epidemiological assessment and provide a stool sample prior to endoscopy for qualitative Fecal Immunochemical Test (FIT), quantitative Fecal Immunochemical Test (FIT), and novel biomarker testing, followed by the endoscopic examination. After completion of the baseline endoscopic screening, all enrolled participants will undergo a 2-year follow-up. The primary endpoints of the study are sensitivity and specificity for the screening of gastrointestinal cancers.The aim of this study is to develop and evaluate the sensitivity and specificity of fecal multi-marker panels for the screening of gastrointestinal cancers.
- Conditions
- Gastric Cancer, Colorectal Cancer
- Being tested
- Qualitative Fecal Immunochemical Test (FIT), quantitative (FIT), and testing for new biomarkers
- Medical subject headings
- Stomach Neoplasms, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Qualitative Fecal Immunochemical Test (FIT), quantitative (FIT), and testing for new biomarkersDiagnostic test
Stool samples are collected from participants before endoscopy for qualitative Fecal Immunochemical Test (FIT), quantitative Fecal Immunochemical Test (FIT), and novel biomarker testing. The results are used to screen for gastrointestinal cancers.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity and Specificity of Stool-Based Biomarker Testing for Gastrointestinal Cancer Screening
Measured: At the time of baseline endoscopic screening, approximately 2 weeks after stool sample collection.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start10 Aug 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Cancer, Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Xijing 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
- 5,000 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
- NCT07600125
- Sponsor's protocol ID
- KY20262030-C-1
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the study is complete, submit a request to the principal investigator. The applicant must provide a data analysis plan, and a decision on whether to share the data will be made following an evaluation.
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fecal Multi-target Biomarkers in the Screening of Digestive Tract Cancers: a Multi-center Prospective Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07600125
- Acronym / sponsor ID
- KY20262030-C-1
- Conditions
- Gastric Cancer, Colorectal Cancer
- 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 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 20 May 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 multi-center, observational study. Participants scheduled for gastroscopy and colonoscopy will undergo an epidemiological assessment and provide a stool sample prior to endoscopy for qualitative Fecal Immunochemical Test (FIT), quantitative Fecal Immunochemical Test (FIT), and novel biomarker testing, followed by the endoscopic examination. After completion of the baseline endoscopic screening, all enrolled participants will undergo a 2-year follow-up. The primary endpoints of the study are sensitivity and specificity for the screening of gastrointestinal cancers.The aim of this study is to develop and evaluate the sensitivity and specificity of fecal multi-marker panels for the screening of gastrointestinal cancers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study will enroll individuals aged 18 and older who are scheduled to undergo gastrointestinal endoscopy and are willing to participate in the screening.
Key inclusion criteria (4 listed)
- Participants must be at least 18 years of age at the time of enrollment;
- Participants must be scheduled to undergo gastroscopy and colonoscopy;
- Participants must agree to undergo a two-year follow-up as outlined in the protocol;
- Participants must be willing to participate and sign an informed consent form.
Key exclusion criteria (5 listed)
- Have undergone gastrointestinal endoscopy screening within the past year;
- History of any type of gastrointestinal malignancy;
- 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 |
|---|---|---|
| Qualitative Fecal Immunochemical Test (FIT), quantitative (FIT), and testing for new biomarkersStool samples are collected from participants before endoscopy for qualitative Fecal Immunochemical Test (FIT), quantitative Fecal Immunochemical Test (FIT), and novel biomarker testing. The results are used to screen for gastrointestinal cancers. | Diagnostic test | – |
Primary outcome
Sensitivity and Specificity of Stool-Based Biomarker Testing for Gastrointestinal Cancer Screening
Time frame: At the time of baseline endoscopic screening, approximately 2 weeks after stool sample collection.
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 11 Aug 2026.
- Individual participant dataSharing planned: Yes. Once the study is complete, submit a request to the principal investigator. The applicant must provide a data analysis plan, and a decision on whether to share the data will be made following an evaluation.
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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.
13 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric Cancer, Colorectal Cancer, run by Xijing Hospital at 13 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 11 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 13 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 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 and Specificity of Stool-Based Biomarker Testing for Gastrointestinal Cancer Screening (time frame: At the time of baseline endoscopic screening, approximately 2 weeks after stool sample collection.). 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 11 Aug 2026.