Cohort Study for Gastric MALT Lymphoma

NCT06454149 | Recruiting

• 1 other identifier: HUG-MALToma
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 3

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).

Conditions

Gastric MALT Lymphoma

Outcome Measures

Primary Outcomes (1)

• Remission of gastric MALT lymphoma

  Remission of gastric MALT lymphoma

  Within 3 years from diagnosis

Secondary Outcomes (1)

• Eradication of H. pylori infection

  Within 6 month from eradication therapy

Study Arms (2)

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

MALT lymphoma OTHER

New diagnosis with gastric MALT lymphoma

MALT lymphoma

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \[MALT lymphoma group\]
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead
• Kangbuk Samsung Hospital: collaborator
• Korea University Ansan Hospital: collaborator

Study Sites (3)

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

Related Publications (4)

• 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.

  PMID: 31912792 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

MeSH Terms

Interventions

MALT1 protein, human

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 6, 2024
• First Posted: June 12, 2024
• Study Start: June 6, 2024
• Primary Completion (Estimated): June 5, 2028
• Study Completion (Estimated): June 5, 2031
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)