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Status unknownNCT06079554Updated Apr 12, 2024

Microbiota and Metabolomics of Intestinal Type of Gastric Cancer

An observational study in Gastric Cancer, sponsored by Jilin University. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-04-12.

Sponsored by Jilin University · Observational

The sponsor has not verified this record recently (last verified Apr 2024), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
32
Ages
18 Years to 80 Years
Sex
All
01

Study summary

Compare with the gastric cavity without cancerous transformation in atrophic gastritis, analyze the microbiota and metabolomics changes in intestinal type of gastric cancer under the background of atrophic gastritis, and explore the relevant mechanisms.

Read the detailed description

This study adopts a prospective cohort study. The expected recruitment time for all participants is 6 months, and all cases are cases who would receive magnifying endoscopy examination. The extent of atrophy and the presence of early gastric cancer are determined under magnifying endoscopy. Cases are chose into the gastric cancer group and atrophic gastritis group in a 1:1 ratio. There are 16 cases of intestinal type of gastric cancer under the background of atrophic gastritis, and 16 cases of atrophic gastritis without gastric cancer matched according to gender, age, and degree of gastric atrophy, totaling 32 cases. Analyze the characteristics of early gastric cancer under endoscopy, investigate the changes in microbiota and metabolomics of intestinal type of gastric cancer under the background of atrophic gastritis, and explore the relevant mechanisms.

02

Conditions studied

  • Gastric Cancer

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03

In context

Stomach Neoplasms

2,914 studies on the registry are indexed under Stomach Neoplasms; 881 are open to participants now.

This study's planned enrollment of 32 is below the median of 281 across 684 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Jilin University is the lead sponsor of 27 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

We underwent magnifying staining endoscopy examination in our hospital and diagnosed cases of atrophic gastritis with or without gastric cancer under endoscopy.

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

  • •Intestinal type of gastric cancer or atrophic gastritis

    • Underwent Endoscopic submucosal dissection(ESD)

Exclusion criteria

Exclusion Criteria:

    • have simultaneously other cancer

      • have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
32 participants (estimated)
Target follow-up
12 Months
Patient registry
Yes

Groups and cohorts

  • the gastric cancer group

    16 cases of intestinal type of gastric cancer under the background of atrophic gastritis

  • the atrophic gastritis group

    16 cases of atrophic gastritis without gastric cancer matched according to gender, age, and degree of gastric atrophy

06

What researchers measure

Primary outcomes

  1. Metabolomics results of lesions and atrophic gastritis.

    liquid chromatograph mass spectrometer metabolic profling

    Time frame: 1year

Secondary outcomes

  1. microbiomics of lesions and atrophic gastritis.

    16SrRNA analysis

    Time frame: 1 year

Other outcomes

  1. degree of gastric atrophy,

    According to the classification of Kimura-Takemoto Classification (C1-O3)

    Time frame: 1year

  2. endoscopic observation

    NBI observation of atrophic background color, surrounding color of the lesion, lesion color, presence or absence of boundary transition zones, scattered intact glands within the lesion,presence of incomplete mesh patterns, and presence or absence of other early gastric cancer endoscopic manifestations.

    Time frame: 1year

07

Study locations

1 of 1 sites recruiting
  • the First Hospital of Jilin University
    Changchun, Jilin 130021, China
    • Dong Yang, Master · Contact
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

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

Started Mar 2024 (actual). Primary completion is estimated for Apr 2024, 0 months after the start.

Of 274 non-industry observational studies under Stomach Neoplasms, half reached primary completion within 59 months of starting (the median), counting those still running; a quarter within 30 and three quarters within 171. This study's planned 0 months is below that.

Counting every sponsor, half of 305 studies reached it within 56 months; a quarter within 30 and three quarters within 120.

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

Registered
Oct 6, 2023
First posted
Oct 12, 2023
StartActual
Mar 31, 2024
Primary completionEst.
Apr 28, 2024
CompletionEst.
Aug 30, 2025
Last update
Apr 12, 2024
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 Apr 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06079554
Lead sponsor
Jilin University
Responsible party
Dong Yang (Assisted Investigator, Jilin University) — Principal investigator
First posted
Oct 12, 2023
Start date
Mar 31, 2024
Primary completion
Apr 28, 2024 (estimated)
Completion
Aug 30, 2025 (estimated)
Last update
Apr 12, 2024

Study contacts

Hong Xu, professor
Contact
18844097668@163.com
18844097668
Dong Yang, doctor
Contact

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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