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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

Tracking Information
First Submitted Date February 15, 2017
First Posted Date February 17, 2017
Last Update Posted Date March 18, 2019
Actual Study Start Date May 2015
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 16, 2017)		 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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title A Study on the Gastrointestinal Disease and Helicobacter Pylori Controlled Long Non-coding RNA
Official Title A Study on the Gastrointestinal Disease and Helicobacter Pylori Controlled Long Non-coding RNA
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
EGD, forcep biopsy
Sampling Method Non-Probability Sample
Study Population Patients with gastrointestinal disease associated with H.pylori infection
Condition
  • Helicobacter Pylori Infection
  • Gastric Ulcer
  • Duodenal Ulcer
  • Stomach Cancer
Intervention Not Provided
Study Groups/Cohorts
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 16, 2017)		 50
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2020
Estimated Primary Completion Date April 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Sang Kil Lee, MD 82-2-2228-1996 sklee@yuhs.ac
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT03057171
Other Study ID Numbers 4-2015-0146
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Yonsei University
Study Sponsor Yonsei University
Collaborators Not Provided
Investigators Not Provided
PRS Account Yonsei University
Verification Date March 2019