A Study on the Gastrointestinal Disease and Helicobacter... | NCT03057171

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

NCT03057171

Sponsor

Yonsei University

Status

Unknown status

Last Update Posted

Mar 18, 2019Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Helicobacter Pylori Infection
Gastric Ulcer
Duodenal Ulcer
Stomach Cancer

Interventions

Not provided

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2015Actual

Primary Completion Date

Apr 2020Estimated

Completion Date

Apr 2020Estimated

First Submitted Date

Feb 15, 2017

First Submission Date that Met QC Criteria

Feb 16, 2017

First Posted Date

Feb 17, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2019

Last Update Posted Date

Mar 18, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Expression of THRIL, PACER	Expression of THRIL, PACER according to Helicobacter pylori infection by Real-time aRT-PCR	Within 2 weeks after EGD

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients with gastrointestinal disease associated with H.pylori infection

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Sang Kil Lee, MD	Contact	82-2-2228-1996		sklee@yuhs.ac

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Yonsei university College of Medicine	Recruiting	Seoul		03722	South Korea

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D013276	Stomach Ulcer
D004381	Duodenal Ulcer
D013274	Stomach Neoplasms

Ancestor Terms

ID	Term
D010437	Peptic Ulcer
D004378	Duodenal Diseases
D007410	Intestinal Diseases
D005767	Gastrointestinal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided