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RecruitingNCT06454149HUG-MALTomaUpdated Sep 28, 2026

Cohort Study for Gastric MALT Lymphoma

An observational study in Gastric MALT Lymphoma, sponsored by Seoul National University Hospital. Recruiting at 3 sites in South Korea. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Seoul National University Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 75 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Gastric MALT Lymphoma
03

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
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.

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

Exclusion Criteria:

  • History of gastric or other malignancy
  • Use of antibiotics or probiotics within 4 weeks
  • Uncontrolled chronic illnesses
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (estimated)
Target follow-up
3 Years
Patient registry
Yes

Groups and cohorts

  • MALT lymphoma

    Patients who were newly diagnosed as gastric MALT lymphoma

    Other: 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.

Interventions

  • OtherMALT lymphoma

    New diagnosis with gastric MALT lymphoma

05

What researchers measure

Primary outcomes

  1. Remission of gastric MALT lymphoma

    Remission of gastric MALT lymphoma

    Time frame: Within 3 years from diagnosis

Secondary outcomes

  1. Eradication of H. pylori infection

    Eradication of H. pylori infection

    Time frame: Within 6 month from eradication therapy

06

Study locations

2 of 3 sites recruiting
  • Korea University Ansan Hospital
    Ansan-si, Gyeonggi-do 15355, South Korea
    Not yet recruiting
  • Cheol Min Shin
    Seongnam-si, Gyeonggi-do 463-707, South Korea
    Recruiting
  • Kangbuk Samsung Hospital
    Seoul, 03181, South Korea
    Recruiting
07

References and documents

Publications

  • Zucca E, Arcaini L, Buske C, Johnson PW, Ponzoni M, Raderer M, Ricardi U, Salar A, Stamatopoulos K, Thieblemont C, Wotherspoon A, Ladetto M; ESMO Guidelines Committee. Electronic address: clinicalguidelines@esmo.org. Marginal zone lymphomas: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up. Ann Oncol. 2020 Jan;31(1):17-29. doi: 10.1016/j.annonc.2019.10.010. Epub 2019 Dec 4. No abstract available. PubMed 31912792 ↗
  • Di Rocco A, Petrucci L, Assanto GM, Martelli M, Pulsoni A. Extranodal Marginal Zone Lymphoma: Pathogenesis, Diagnosis and Treatment. Cancers (Basel). 2022 Mar 29;14(7):1742. doi: 10.3390/cancers14071742. PubMed 35406516 ↗
  • Tanaka T, Matsuno Y, Torisu T, Shibata H, Hirano A, Umeno J, Kawasaki K, Fujioka S, Fuyuno Y, Moriyama T, Esaki M, Kitazono T. Gastric microbiota in patients with Helicobacter pylori-negative gastric MALT lymphoma. Medicine (Baltimore). 2021 Sep 24;100(38):e27287. doi: 10.1097/MD.0000000000027287. PubMed 34559138 ↗
  • Lemos FFB, Silva Luz M, Rocha Pinheiro SL, Teixeira KN, Freire de Melo F. Role of non-Helicobacter pylori gastric Helicobacters in helicobacter pylori-negative gastric mucosa-associated lymphoid tissue lymphoma. World J Gastroenterol. 2023 Aug 28;29(32):4851-4859. doi: 10.3748/wjg.v29.i32.4851. PubMed 37701138 ↗

Individual participant data

Plan to share: No — IPD will not be shared due to data protection policy of the participating institutions.

08

Registry details

Key details

Study ID
NCT06454149
Lead sponsor
Seoul National University Hospital
Collaborators
Kangbuk Samsung Hospital, Korea University Ansan Hospital
Responsible party
Cheol Min Shin (Professor, Seoul National University Hospital) — Principal investigator
First posted
Jun 12, 2024
Start date
Jun 6, 2024
Primary completion
Jun 5, 2028 (estimated)
Completion
Jun 5, 2031 (estimated)
Last update
Sep 28, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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