Gastric XanthomaNCT06282484
A Study on the Relationship Between Gastric Xanthoma and Gastric Cancer and Precancerous Lesions
An observational study of Gastric Xanthoma and Helicobacter Pylori Infection, run by Xijing Hospital of Digestive Diseases at 1 site in China.
Trial summary
To explore the effects of gastric xanthoma on gastric cancer and its precancerous lesions, so as to better prevent the occurrence and development of gastric cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric Xanthoma, Helicobacter Pylori Infection, Gastric Cancer
- How many people
- 1,260 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 29 Sep 2023
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undergoing upper gastrointestinal endoscopy at Xijing Hospital
Who may be able to join
- Age range from 18 to 75 years old, regardless of gender;
- Endoscopic/pathological diagnosis: chronic non atrophic gastritis/chronic atrophic gastritis/intestinal metaplasia/dysplasia Hyperplasia/gastric cancer
- Voluntarily sign an informed consent form.
Who cannot join
- Previously underwent upper gastrointestinal surgery
- Previous diagnosis of malignant tumors
- Individuals who are unable to cooperate with the questionnaire survey due to mental disorders or other reasons
- Those who cannot be observed by endoscopy due to acute upper gastrointestinal bleeding or other reasons
Trial locations and contacts
1 site in 1 country.
About this study
To explore the effects of gastric xanthoma on gastric cancer and its precancerous lesions, so as to better prevent the occurrence and development of gastric cancer.
Read the detailed description
This is a large-scale single center case-control study. Patients were consecutively enrolled and divided into gastric cancer group, gastric precancerous lesions group, and chronic gastritis group, according to histopathological results.Record the location and quantity of gastric xanthoma and situation of Helicobacter pylori infection in each patient.
- Conditions
- Gastric Xanthoma, Helicobacter Pylori Infection, Gastric Cancer, Intestinal Metaplasia, Precancerous Lesions
- Keywords
- gastric cancer, helicobacter pylori, precancerous lesion, Gastric Xanthoma
- Medical subject headings
- Stomach Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| chronic gastritis | patients with chronic non-atrophic gastritis and chronic atrophic gastritis according to histopathological results | |
| precancerous lesion | patients with gastric intestinal metaplasia and intraepithelial neoplasia according to histopathological results | |
| gastric cancer | patients with gastric cancer according to histopathological results |
What is being measured
The primary outcome is the main question the study is designed to answer.
corelation between the gastric xanthoma and gastric mucosa diseases
we evaluate the corelation between the gastric xanthoma and gastric mucosa diseases according to the histopathological results and the scales the patients finished
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2024
- Study start1 Sep 2022
- Primary completion1 Jun 2023
- Study completion29 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric XanthomaStudies 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
- 1,260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Xijing Hospital of Digestive Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yongquan Shi, Xijing Hospital of Digestive Diseases
- Investigators
- Yongquan Shi, PhD, Study director, Xijing Hosipital of Digestive Disease
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06282484
- Sponsor's protocol ID
- KY20232348-C-1
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 28 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Relationship Between Gastric Xanthoma and Gastric Cancer and Precancerous Lesions
- ClinicalTrials.gov ID
- NCT06282484
- Acronym / sponsor ID
- KY20232348-C-1
- Conditions
- Gastric Xanthoma, Helicobacter Pylori Infection, Gastric Cancer, Intestinal Metaplasia, Precancerous Lesions
- Keywords
- gastric cancer, helicobacter pylori, precancerous lesion, Gastric Xanthoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,260 participants (actual)
- Lead sponsor
- Xijing Hospital of Digestive DiseasesUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 29 Sep 2023 (actual)
- First posted
- 28 Feb 2024 (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.
To explore the effects of gastric xanthoma on gastric cancer and its precancerous lesions, so as to better prevent the occurrence and development of gastric cancer.
Detailed description
This is a large-scale single center case-control study. Patients were consecutively enrolled and divided into gastric cancer group, gastric precancerous lesions group, and chronic gastritis group, according to histopathological results.Record the location and quantity of gastric xanthoma and situation of Helicobacter pylori infection in each patient.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| chronic gastritis | – | –patients with chronic non-atrophic gastritis and chronic atrophic gastritis according to histopathological results |
| precancerous lesion | – | –patients with gastric intestinal metaplasia and intraepithelial neoplasia according to histopathological results |
| gastric cancer | – | –patients with gastric cancer according to histopathological results |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing upper gastrointestinal endoscopy at Xijing Hospital
Key inclusion criteria (3 listed)
- Age range from 18 to 75 years old, regardless of gender;
- Endoscopic/pathological diagnosis: chronic non atrophic gastritis/chronic atrophic gastritis/intestinal metaplasia/dysplasia Hyperplasia/gastric cancer
- Voluntarily sign an informed consent form.
Key exclusion criteria (4 listed)
- Previously underwent upper gastrointestinal surgery
- Previous diagnosis of malignant tumors
- Individuals who are unable to cooperate with the questionnaire survey due to mental disorders or other reasons
- Those who cannot be observed by endoscopy due to acute upper gastrointestinal bleeding or other reasons
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
corelation between the gastric xanthoma and gastric mucosa diseases
Time frame: up to 6 months
we evaluate the corelation between the gastric xanthoma and gastric mucosa diseases according to the histopathological results and the scales the patients finished
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2024.
- Individual participant dataSharing planned: No
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.
Yongquan Shi, PhD study director
Xijing Hosipital of Digestive Disease
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 Gastric Xanthoma and Helicobacter Pylori Infection, run by Xijing Hospital of Digestive Diseases 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 28 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corelation between the gastric xanthoma and gastric mucosa diseases (time frame: up to 6 months). 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 28 Feb 2024.