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Clinical Trials/NCT06454149
NCT06454149RecruitingNot Applicable

Establishment of a Cohort for Investigating the Pathophysiology of Gastric MALT Lymphoma

Seoul National University Hospital6 sites in 2 countries300 target enrollmentStarted: June 6, 2024Last updated:
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Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
300
Locations
6
Primary Endpoint
Remission of gastric MALT lymphoma
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The goal of this observational study is to establish clinical data and tissue repository in patients with gastric MALT lymphoma and controls.

Participants will be asked to provide clinical information and various tissues (saliva, gastric mucosa, and feces).

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •[MALT lymphoma group]
  • •Newly diagnosed as gastric MALT lymphoma [Control group]
  • •Patients who underwent
  • •diagnosed upper endoscopy for dyspepsia and had chronic gastritis,
  • •therapeutic upper endoscopy for gastric hyperplastic polyps, or
  • •screening upper endoscopy without any symptoms.

Exclusion Criteria

  • •History of gastric or other malignancy
  • •Use of antibiotics or probiotics within 4 weeks
  • •Uncontrolled chronic illnesses

Arms & Interventions

MALT lymphoma

Patients who were newly diagnosed as gastric MALT lymphoma

Intervention: MALT lymphoma (Other)

Control group

Patients who underwent

  1. diagnosed upper endoscopy for dyspepsia and had chronic gastritis,
  2. therapeutic upper endoscopy for gastric hyperplastic polyps, or
  3. screening upper endoscopy without any symptoms.

Outcomes

Primary Outcomes

Remission of gastric MALT lymphoma

Time Frame: Within 3 years from diagnosis

Remission of gastric MALT lymphoma

Secondary Outcomes

  • Eradication of H. pylori infection(Within 6 month from eradication therapy)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Cheol Min Shin

Professor

Seoul National University Hospital

Study Sites (6)

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