ClinicalTrials.gg
RecruitingNCT07769892Updated Aug 18, 2026

A Multicenter Prospective Observational Cohort Study for Digestive Tract Tumor Screening Using Multi-Target Blood and Fecal Biomarkers

An observational study in Gastrointestinal Cancers, sponsored by Xijing Hospital. Recruiting at 7 sites in China. Open to participants aged 45 Years to 74 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-18.

Sponsored by Xijing Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
5,000
Ages
45 Years to 74 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 109 studies in Gastrointestinal Neoplasms with a site in China — 43 open to participants now, 50 under way, 6 of them phase 3. Gastrointestinal Neoplasms · China.

Planned enrollment
3rd of 22
5,000 · median 500
Started
2026
with 10 others
Observational
22 of 109
7 open now
Primary completion
2035-12
later than 49 of 49 live
Registered
106th of 109
by date

Among the 109 studies in Gastrointestinal Neoplasms with a site in China, this one is the 3rd largest by planned enrollment of the 22 observational ones that give a count, is one of 11 that started in 2026, is one of 22 observational ones, reaches primary completion later than 49 of the 49 other live ones, and was the 106th registered.

Gastrointestinal Neoplasms

696 studies on the registry are indexed under Gastrointestinal Neoplasms; 210 are open to participants now.

Browse Gastrointestinal Neoplasms studies →

Open to participants now

43 of the 109 studies in Gastrointestinal Neoplasms with a site in China are open now. Recruiting first, the newest first:

37 more — sign in →

All 43 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 160 Gastrointestinal Neoplasms studies recruiting now, 122 (76%) set no upper age limit and 18 (11%) stop at 75 or younger; 8 take children under 18; 9 take healthy volunteers.

This study: 45 Years to 74 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

Was this useful?
Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 109 studies in Gastrointestinal Neoplasms with a site in China, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Gastrointestinal Cancers
04

Who can participate

Ages eligible
45 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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 .

Exclusion criteria

Exclusion Criteria:

  • 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 ); 5.Pregnant or lactating women.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
5,000 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

  2. Specificity of combined biomarkers for pan-digestive tract cancer screening

    Time frame: Day 1 At endoscopy and pathological confirmation after enrollment

Secondary outcomes

  1. Detection rate of precancerous lesions of digestive tract by blood multi-gene methylation combined with fecal biomarkers.

    Time frame: 5 years after enrollment

  2. Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for esophageal cancer screening

    Time frame: 5 years after enrollment

  3. Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for gastric cancer screening

    Time frame: 5 years after enrollment

  4. Sensitivity and specificity of blood multi-gene methylation combined with fecal biomarkers for colorectal cancer screening

    Time frame: 5 years after enrollment

  5. 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

  6. 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

  7. 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

  8. 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

07

Study locations

7 of 7 sites recruiting
08

References and documents

Individual participant data

Plan to share: 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.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Dec 2035, 112 months later.

Of 79 non-industry observational studies under Gastrointestinal Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 102. This study's planned 112 months is above that.

Counting every sponsor, half of 88 studies reached it within 43 months; a quarter within 16 and three quarters within 102.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 13, 2026
First posted
Aug 18, 2026
StartEst.
Aug 10, 2026
Primary completionEst.
Dec 31, 2035
CompletionEst.
Dec 31, 2035
Last update
Aug 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07769892
Lead sponsor
Xijing Hospital
Responsible party
Sponsor
First posted
Aug 18, 2026
Start date
Aug 10, 2026 (estimated)
Primary completion
Dec 31, 2035 (estimated)
Completion
Dec 31, 2035 (estimated)
Last update
Aug 18, 2026

Study contacts

Rong Zheng
Contact
zhengrong4956@163.com
+86 198 2975 8242
Yongzhan Nie
principal investigator · Xijing Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion