Helicobacter Pylori InfectionNCT03057171
A Study on the Gastrointestinal Disease and Helicobacter Pylori Controlled Long Non-coding RNA
An observational study of Helicobacter Pylori Infection and Gastric Ulcer, run by Yonsei University at 1 site in South Korea.
Trial summary
Helicobacter pylori (H.pylori) is a major human pathogenic bacterium in gastric mucosa which is linked to the development of gastritis, peptic ulcer disease, mucosa-associated lymphoid tissue lymphoma and gastric cancer. However the regulatory mechanism of H.pylori-induced immune response is not clear. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Helicobacter Pylori Infection, Gastric Ulcer, Duodenal Ulcer
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2015to Apr 2020
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with gastrointestinal disease associated with H.pylori infection
Who may be able to join
- Over 19 years old
- Patients with gastric ulcer
- Patients with duodenal ulcer
- Patients with stomach cancer
- Patients with gastrointestinal discomfort symptoms
Who cannot join
- Patients who has done helicobacter pylori eradication
- Patients who has undergone gastrectomy
- Patients who has undergone endoscopic submucosal dissection
- Patients with active upper gastrointestinal bleeding
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Yonsei university College of Medicine
Seoul, 03722
Sang Kil Lee, MD, 82-2-2228-1996, sklee@yuhs.ac
About this study
Helicobacter pylori (H.pylori) is a major human pathogenic bacterium in gastric mucosa which is linked to the development of gastritis, peptic ulcer disease, mucosa-associated lymphoid tissue lymphoma and gastric cancer. However the regulatory mechanism of H.pylori-induced immune response is not clear. Long non-coding RNA (lncRNA) has recently emerged as key post-transcriptional regulators of gene expression, differentiation. The investigators had a preliminary results which THRIL (TNFα and hnRNPL related immunoregulatory lincRNA) and PACER(p50-associated COX-2 extragenic RNA) played a potential role in H.pylori induced inflammatory cascade. However, there wasn't a previous study about expression of THRIL, PACER in a human tissue. Therefore, the investigators aimed to evaluate the expression of THRIL, PACER in patients with gastrointestinal disease according to H.pylori infection.
- Keywords
- Helicobacter pylori, long non-coding RNA, THRIL, PACER, cagA
- Medical subject headings
- Stomach Ulcer, Duodenal Ulcer, 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 |
|---|---|---|
| Gastric ulcer | patients who will undergo EGD for gastric ulcer | |
| Duodenal ulcer | patients who will undergo EGD for duodenal ulcer | |
| Stomach cancer | patients who will undergo EGD for stomach cance | |
| health individuals | patients who will undergo screening EGD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of THRIL, PACER
Expression of THRIL, PACER according to Helicobacter pylori infection by Real-time aRT-PCR
Measured: Within 2 weeks after EGD
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2017
- Study startMay 2015
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Helicobacter Pylori InfectionStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057171
- Sponsor's protocol ID
- 4-2015-0146
- Status last verified
- Mar 2019
- First submitted
- 15 Feb 2017
- Last updated
- 18 Mar 2019
- Results posted
- No
- Data monitoring committee
- 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 18 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on the Gastrointestinal Disease and Helicobacter Pylori Controlled Long Non-coding RNA
- ClinicalTrials.gov ID
- NCT03057171
- Acronym / sponsor ID
- 4-2015-0146
- Keywords
- Helicobacter pylori, long non-coding RNA, THRIL, PACER, cagA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- May 2015 (actual)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 17 Feb 2017 (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.
Helicobacter pylori (H.pylori) is a major human pathogenic bacterium in gastric mucosa which is linked to the development of gastritis, peptic ulcer disease, mucosa-associated lymphoid tissue lymphoma and gastric cancer. However the regulatory mechanism of H.pylori-induced immune response is not clear. Long non-coding RNA (lncRNA) has recently emerged as key post-transcriptional regulators of gene expression, differentiation. The investigators had a preliminary results which THRIL (TNFα and hnRNPL related immunoregulatory lincRNA) and PACER(p50-associated COX-2 extragenic RNA) played a potential role in H.pylori induced inflammatory cascade. However, there wasn't a previous study about expression of THRIL, PACER in a human tissue. Therefore, the investigators aimed to evaluate the expression of THRIL, PACER in patients with gastrointestinal disease according to H.pylori infection.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Gastric ulcer | – | –patients who will undergo EGD for gastric ulcer |
| Duodenal ulcer | – | –patients who will undergo EGD for duodenal ulcer |
| Stomach cancer | – | –patients who will undergo EGD for stomach cance |
| health individuals | – | –patients who will undergo screening EGD |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with gastrointestinal disease associated with H.pylori infection
Key inclusion criteria (5 listed)
- Over 19 years old
- Patients with gastric ulcer
- Patients with duodenal ulcer
- Patients with stomach cancer
- Patients with gastrointestinal discomfort symptoms
Key exclusion criteria (4 listed)
- Patients who has done helicobacter pylori eradication
- Patients who has undergone gastrectomy
- Patients who has undergone endoscopic submucosal dissection
- Patients with active upper gastrointestinal bleeding
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
Expression of THRIL, PACER
Time frame: Within 2 weeks after EGD
Expression of THRIL, PACER according to Helicobacter pylori infection by Real-time aRT-PCR
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2019.
- Individual participant dataSharing planned: No
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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 Helicobacter Pylori Infection and Gastric Ulcer, run by Yonsei University at 1 site in South Korea.
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 5 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: status not confirmed, as of the sponsor's last update on 18 Mar 2019. 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 South Korea. 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 Sang Kil Lee, MD (82-2-2228-1996, sklee@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Expression of THRIL, PACER (time frame: Within 2 weeks after EGD). 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 18 Mar 2019.