Cohort Study for Gastric MALT Lymphoma (HUG-MALToma)

June 6, 2024 updated by: Cheol Min Shin, Seoul National University Hospital

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 03181
        • Recruiting
        • Kangbuk Samsung Hospital
        • Contact:
    • Gyeonggi-do
      • Ansan-si, Gyeonggi-do, Korea, Republic of, 15355
        • Not yet recruiting
        • Korea University Ansan Hospital
        • Contact:
      • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
        • Recruiting
        • Cheol Min Shin
        • Contact:
          • Cheol Min Shin, M.D., Ph.D.
          • Phone Number: + 82-31-787-7057
          • Email: scm6md@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Eligible patients who visited participating hospital will be asked, and upon providing informed consent, will be enrolled in the study.

Description

Inclusion Criteria:

[MALT lymphoma group]

  • Newly diagnosed as gastric MALT lymphoma [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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
MALT lymphoma
Patients who were newly diagnosed as gastric MALT lymphoma
Other: MALT lymphoma
New diagnosis with gastric MALT lymphoma
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission of gastric MALT lymphoma
Time Frame: Within 3 years from diagnosis
Remission of gastric MALT lymphoma
Within 3 years from diagnosis

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eradication of H. pylori infection
Time Frame: Within 6 month from eradication therapy
Eradication of H. pylori infection
Within 6 month from eradication therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Collaborators

Kangbuk Samsung Hospital
Korea University Ansan Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2024

Primary Completion (Estimated)

June 5, 2028

Study Completion (Estimated)

June 5, 2031

Study Registration Dates

First Submitted

June 6, 2024

First Submitted That Met QC Criteria

June 6, 2024

First Posted (Actual)

June 12, 2024

Study Record Updates

Last Update Posted (Actual)

June 12, 2024

Last Update Submitted That Met QC Criteria

June 6, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HUG-MALToma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared due to data protection policy of the participating institutions.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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