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Recruiting NCT06454149

Cohort Study for Gastric MALT Lymphoma

Observational Gastric MALT Lymphoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MALT lymphoma.
Who it may be relevant to
Registry conditions: Gastric MALT Lymphoma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

Interventions

  • Other MALT lymphoma
    New diagnosis with gastric MALT lymphoma

Primary outcome measures

  • Remission of gastric MALT lymphoma [Time frame: Within 3 years from diagnosis]
Secondary outcome measures (1)
  • Eradication of H. pylori infection [Time frame: Within 6 month from eradication therapy]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

South Korea · 3 centers
  • Korea University Ansan Hospital — Ansan-si
  • Cheol Min Shin — Seongnam-si
  • Kangbuk Samsung Hospital — Seoul

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. PMID 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. PMID 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. PMID 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. PMID 37701138

Identifiers

NCT: NCT06454149 · HUG-MALToma

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗