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

NCT03057171 | Unknown

• 1 other identifier: 4-2015-0146
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Helicobacter Pylori Infection; Gastric Ulcer; Duodenal Ulcer; Stomach Cancer

Keywords

Helicobacter pylori; long non-coding RNA; THRIL; PACER; cagA

Outcome Measures

Primary Outcomes (1)

• Expression of THRIL, PACER

  Expression of THRIL, PACER according to Helicobacter pylori infection by Real-time aRT-PCR

  Within 2 weeks after EGD

Study Arms (4)

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

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with gastrointestinal disease associated with H.pylori infection

You may qualify if:

• Over 19 years old
• Patients with gastric ulcer
• Patients with duodenal ulcer
• Patients with stomach cancer
• Patients with gastrointestinal discomfort symptoms

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei university College of Medicine

Seoul, 03722, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

EGD, forcep biopsy

MeSH Terms

Conditions

Stomach Ulcer; Duodenal Ulcer; Stomach Neoplasms

Condition Hierarchy (Ancestors)

Peptic Ulcer; Duodenal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Stomach Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms

Central Study Contacts

Sang Kil Lee, MD

CONTACT

82-2-2228-1996; sklee@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 17, 2017
• Study Start: May 1, 2015
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: March 18, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)