Cohort Study for Gastric MALT Lymphoma

Gastric MALT Lymphoma Clinical Trial

— HUG-MALToma  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06454149
• Other study ID #: HUG-MALToma
• Status: Recruiting
• Start date: June 6, 2024
• Est. completion date: June 5, 2031

Study information

• Verified date: June 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 5, 2031
• Est. primary completion date: June 5, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gastric MALT Lymphoma
• Lymphoma
• Lymphoma, B-Cell, Marginal Zone
• Lymphoma, Non-Hodgkin
• Stomach Neoplasms

Intervention

Other:
• MALT lymphoma
New diagnosis with gastric MALT lymphoma

Locations

Country	Name	City	State
Korea, Republic of	Korea University Ansan Hospital	Ansan-si	Gyeonggi-do
Korea, Republic of	Cheol Min Shin	Seongnam-si	Gyeonggi-do
Korea, Republic of	Kangbuk Samsung Hospital	Seoul

Sponsors (3)

Lead Sponsor	Collaborator
Seoul National University Hospital	Kangbuk Samsung Hospital, Korea University Ansan Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View 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. — View 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. — View 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. Erratum In: Ann Oncol. 2023 Mar;34(3):325. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission of gastric MALT lymphoma	Remission of gastric MALT lymphoma	Within 3 years from diagnosis
Secondary	Eradication of H. pylori infection	Eradication of H. pylori infection	Within 6 month from eradication therapy