Malignant Tumor of Digestive TractNCT06118437
Establishment and Validation of a Clinical Predictive Model for Gastrointestinal Cancer Screening Based on Patient-related Risk Factors
An observational study of Malignant Tumor of Digestive Tract and Risk Factors, run by Air Force Military Medical University, China at 1 site in China.
Trial summary
Gastrointestinal tumors (esophageal cancer, gastric cancer, colorectal cancer) seriously threaten human health, with a high incidence rate and cancer related hope mortality. Digestive endoscopy is the main method for screening gastrointestinal tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Malignant Tumor of Digestive Tract, Risk Factors
- How many people
- 1,550 participants
- Where
- 1 siteChina
- Study dates
- 15 Jul 2023to Jul 2025
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Continuous patients who underwent both gastroscopy and colonoscopy at the digestive endoscopy center from October 2023 to May 2025
Who may be able to join
- Individuals aged 18-80;
- Undergoing both gastroscopy and colonoscopy simultaneously.
Who cannot join
- History of esophageal, gastric, or colorectal cancer;
- Suspicions of gastrointestinal obstruction or perforation;
- History of gastrointestinal tract surgery;
- Not suitable for endoscopic examination due to serious diseases or unstable hemodynamics;
- Unavailable relevant information;
- Pregnancy or lactation period;
- Unavailable informed consent form.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Xijing of Digestive Diseases
Xi'an, Shaanxi
Yang lin Pan, MD, 862984771536, yanglinpan@hotmail.com
About this study
Official title: Establishment and Validation of a Clinical Predictive Model for Gastrointestinal Cancer Screening Based on Patient-related Risk Factors: a Prospective, Multicenter Cross-sectional Study
Gastrointestinal tumors (esophageal cancer, gastric cancer, colorectal cancer) seriously threaten human health, with a high incidence rate and cancer related hope mortality. Digestive endoscopy is the main method for screening gastrointestinal tumors. Early screening of gastrointestinal tumors can improve the detection of early cancer and improve prognosis. The five-year survival rate of early stage tumors after comprehensive treatment can reach 90%, while the five-year survival rate of late stage tumors is less than 30%. Therefore, the screening of gastrointestinal tumors is very important.
Studies have shown that there are similarities in risk factors for gastrointestinal tumors, such as age, gender, family history, smoking, alcohol consumption, etc. Currently, established digestive malignancies are targeted at a single malignant tumor. At present, there is a lack of understanding of the overall risk factors associated with gastrointestinal tumors and the establishment of relevant risk prediction models.
Therefore, we conducted a prospective, multicenter cross-sectional study to explore the independent risk factors of combined gastrointestinal tumors and establish a risk prediction model for combined screening of gastrointestinal tumors.
- Conditions
- Malignant Tumor of Digestive Tract, Risk Factors
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall detection rate of gastrointestinal cancer
The proportion of at least one type of gastrointestinal malignant tumor detected
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start15 Jul 2023
- Primary completion30 Apr 2025
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Malignant Tumor of Digestive TractStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1,550 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Air Force Military Medical University, China
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanglin Pan, Air Force Military Medical University, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06118437
- Sponsor's protocol ID
- XJLL-KY-20232231
- Status last verified
- Jul 2024
- First submitted
- 1 Nov 2023
- Last updated
- 24 Jul 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
PubMed 33538338Klein EA, Richards D, Cohn A, Tummala M, Lapham R, Cosgrove D, Chung G, Clement J, Gao J, Hunkapiller N, Jamshidi A, Kurtzman KN, Seiden MV, Swanton C, Liu MC. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021 Sep;32(9):1167-1177. doi: 10.1016/j.annonc.2021.05.806. Epub 2021 Jun 24.
PubMed 34176681
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment and Validation of a Clinical Predictive Model for Gastrointestinal Cancer Screening Based on Patient-related Risk Factors: a Prospective, Multicenter Cross-sectional Study
- ClinicalTrials.gov ID
- NCT06118437
- Acronym / sponsor ID
- XJLL-KY-20232231
- Conditions
- Malignant Tumor of Digestive Tract, Risk Factors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,550 participants (estimated)
- Lead sponsor
- Air Force Military Medical University, ChinaUniversity, hospital or other
- Study start
- 15 Jul 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- Jul 2025 (estimated)
- First posted
- 7 Nov 2023 (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.
Gastrointestinal tumors (esophageal cancer, gastric cancer, colorectal cancer) seriously threaten human health, with a high incidence rate and cancer related hope mortality. Digestive endoscopy is the main method for screening gastrointestinal tumors. Early screening of gastrointestinal tumors can improve the detection of early cancer and improve prognosis. The five-year survival rate of early stage tumors after comprehensive treatment can reach 90%, while the five-year survival rate of late stage tumors is less than 30%. Therefore, the screening of gastrointestinal tumors is very important.
Studies have shown that there are similarities in risk factors for gastrointestinal tumors, such as age, gender, family history, smoking, alcohol consumption, etc. Currently, established digestive malignancies are targeted at a single malignant tumor. At present, there is a lack of understanding of the overall risk factors associated with gastrointestinal tumors and the establishment of relevant risk prediction models.
Therefore, we conducted a prospective, multicenter cross-sectional study to explore the independent risk factors of combined gastrointestinal tumors and establish a risk prediction model for combined screening of gastrointestinal tumors.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Continuous patients who underwent both gastroscopy and colonoscopy at the digestive endoscopy center from October 2023 to May 2025
Key inclusion criteria (2 listed)
- Individuals aged 18-80;
- Undergoing both gastroscopy and colonoscopy simultaneously.
Key exclusion criteria (7 listed)
- History of esophageal, gastric, or colorectal cancer;
- Suspicions of gastrointestinal obstruction or perforation;
- History of gastrointestinal tract surgery;
- Not suitable for endoscopic examination due to serious diseases or unstable hemodynamics;
- Unavailable relevant information;
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
Overall detection rate of gastrointestinal cancer
Time frame: 2 years
The proportion of at least one type of gastrointestinal malignant tumor detected
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Background: PubMed 33538338Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
- Background: PubMed 34176681Klein EA, Richards D, Cohn A, Tummala M, Lapham R, Cosgrove D, Chung G, Clement J, Gao J, Hunkapiller N, Jamshidi A, Kurtzman KN, Seiden MV, Swanton C, Liu MC. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021 Sep;32(9):1167-1177. doi: 10.1016/j.annonc.2021.05.806. Epub 2021 Jun 24.
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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.
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 Malignant Tumor of Digestive Tract and Risk Factors, run by Air Force Military Medical University, China 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 7 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: status not confirmed, as of the sponsor's last update on 24 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang lin Pan, MD (862984771536, yanglinpan@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall detection rate of gastrointestinal cancer (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06118437, which also lists 2 linked publications.
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 24 Jul 2025.