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A Study on the Gastrointestinal Disease and Helicobacter Pylori Controlled Long Non-coding RNA

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ClinicalTrials.gov Identifier: NCT03057171
Recruitment Status : Recruiting
First Posted : February 17, 2017
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Yonsei University

Study Description
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Brief 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. 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.

Condition or disease
Helicobacter Pylori Infection Gastric Ulcer Duodenal Ulcer Stomach Cancer

Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Study on the Gastrointestinal Disease and Helicobacter Pylori Controlled Long Non-coding RNA
Actual Study Start Date : May 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
EGD, forcep biopsy

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with gastrointestinal disease associated with H.pylori infection
Criteria

Inclusion Criteria:

  1. Over 19 years old
  2. Patients with gastric ulcer
  3. Patients with duodenal ulcer
  4. Patients with stomach cancer
  5. Patients with gastrointestinal discomfort symptoms

Exclusion Criteria:

  1. Patients who has done helicobacter pylori eradication
  2. Patients who has undergone gastrectomy
  3. Patients who has undergone endoscopic submucosal dissection
  4. Patients with active upper gastrointestinal bleeding
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03057171


Contacts
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Contact: Sang Kil Lee, MD 82-2-2228-1996 sklee@yuhs.ac

Locations
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Korea, Republic of
Yonsei university College of Medicine Recruiting
Seoul, Korea, Republic of, 03722
Contact: Sang Kil Lee, MD    82-2-2228-1996    sklee@yuhs.ac   
Sponsors and Collaborators
Yonsei University
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Yonsei University
ClinicalTrials.gov Identifier: NCT03057171    
Other Study ID Numbers: 4-2015-0146
First Posted: February 17, 2017    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yonsei University:
Helicobacter pylori
long non-coding RNA
THRIL
PACER
cagA
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Diseases
Digestive System Diseases
Stomach Ulcer
Duodenal Ulcer
Ulcer
Pathologic Processes
Gastrointestinal Neoplasms
 Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Stomach Diseases
Peptic Ulcer
Duodenal Diseases
Intestinal Diseases