Cohort Study for Gastric MALT Lymphoma (HUG-MALToma)
September 25, 2026 updated by: Cheol Min Shin, Seoul National University Hospital
Establishment of a Cohort for Investigating the Pathophysiology of Gastric MALT Lymphoma
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).
Study Overview
Study Type
Observational
Enrollment (Estimated)
300
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, South Korea, 03181
- Recruiting
- Kangbuk Samsung Hospital
-
Contact:
- Hyo-Joon Yang, MD. PhD.
- Phone Number: 82-2-2001-8330
- Email: hyojoon.yang@samsung.com
-
-
Gyeonggi-do
-
Ansan-si, Gyeonggi-do, South Korea, 15355
- Not yet recruiting
- Korea University Ansan Hospital
-
Contact:
- Ayoung Lee, MD. PhD.
- Phone Number: 82-31-412-5114
- Email: frisby@naver.com
-
Seongnam-si, Gyeonggi-do, South Korea, 463-707
- Recruiting
- Cheol Min Shin
-
Contact:
- Cheol Min Shin, M.D., Ph.D.
- Phone Number: + 82-31-787-7057
- Email: scm6md@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: COHORT
- Time Perspectives: PROSPECTIVE
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
MALT lymphoma
Patients who were newly diagnosed as gastric MALT lymphoma |
New diagnosis with gastric MALT lymphoma |
|
Control group
Patients who underwent
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Remission of gastric MALT lymphoma
Time Frame: Within 3 years from diagnosis
|
Remission of gastric MALT lymphoma |
Within 3 years from diagnosis
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Eradication of H. pylori infection
Time Frame: Within 6 month from eradication therapy
|
Eradication of H. pylori infection |
Within 6 month from eradication therapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 6, 2024
Primary Completion (Estimated)
June 5, 2028
Study Completion (Estimated)
June 5, 2031
Study Registration Dates
First Submitted
June 6, 2024
First Submitted That Met QC Criteria
June 6, 2024
First Posted (Actual)
June 12, 2024
Study Record Updates
Last Update Posted (Actual)
September 28, 2026
Last Update Submitted That Met QC Criteria
September 25, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUG-MALToma
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD will not be shared due to data protection policy of the participating institutions.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.