Clinical trial NCT06454149: Cohort Study for Gastric MALT Lymphoma
Official title: Establishment of a Cohort for Investigating the Pathophysiology of Gastric MALT Lymphoma
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Gastric MALT Lymphoma
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Kangbuk Samsung Hospital
name: Korea University Ansan Hospital
First posted: 2024-06-12
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


Eligibility criteria: 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

Primary outcomes:
measure: Remission of gastric MALT lymphoma
timeFrame: Within 3 years from diagnosis
Secondary outcomes:
measure: Eradication of H. pylori infection
timeFrame: Within 6 month from eradication therapy
Other outcomes:
Locations:
city: Ansan-si
country: Korea, Republic of
facility: Korea University Ansan Hospital
state: Gyeonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Cheol Min Shin
state: Gyeonggi-do
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.