Gastric MALT LymphomaHUG-MALTomaNCT06454149
Cohort Study for Gastric MALT Lymphoma
An observational study of Gastric MALT Lymphoma, run by Seoul National University Hospital at 3 sites in South Korea.
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). Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastric MALT Lymphoma
- What is being tested?
- MALT lymphoma
- How many people
- 300 participants
- Where
- 3 sitesSouth Korea
- Study dates
- 6 Jun 2024to 5 Jun 2031
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eligible patients who visited participating hospital will be asked, and upon providing informed consent, will be enrolled in the study.
Who may be able to join
- [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.
Who cannot join
- History of gastric or other malignancy
- Use of antibiotics or probiotics within 4 weeks
- Uncontrolled chronic illnesses
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea3 sites, 3 recruiting
- Not yet recruiting
Korea University Ansan Hospital
Ansan-si, Gyeonggi-do, 15355
Ayoung Lee, MD. PhD., 82-31-412-5114, frisby@naver.com
- Recruiting
Cheol Min Shin
Seongnam-si, Gyeonggi-do, 463-707
Cheol Min Shin, M.D., Ph.D., + 82-31-787-7057, scm6md@gmail.com
- Recruiting
Kangbuk Samsung Hospital
Seoul, 03181
Hyo-Joon Yang, MD. PhD., 82-2-2001-8330, hyojoon.yang@samsung.com
About this study
Official title: 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).
- Conditions
- Gastric MALT Lymphoma
- Being tested
- MALT lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MALT lymphomaOther
New diagnosis with gastric MALT lymphoma
| Study group | Role | What they receive |
|---|---|---|
| MALT lymphoma | Patients who were newly diagnosed as gastric MALT lymphoma Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission of gastric MALT lymphoma
Remission of gastric MALT lymphoma
Measured: Within 3 years from diagnosis
Secondary outcomes (1)
Eradication of H. pylori infection
Eradication of H. pylori infection
Measured: Within 6 month from eradication therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start6 Jun 2024
- Primary completion5 Jun 2028 (estimated)
- Study completion5 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Gastric MALT LymphomaStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Kangbuk Samsung Hospital, Korea University Ansan Hospital
- Responsible party
- Principal investigator, Cheol Min Shin, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454149
- Sponsor's protocol ID
- HUG-MALToma
- Acronym
- HUG-MALToma
- Status last verified
- Sep 2026
- First submitted
- 6 Jun 2024
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will not be shared due to data protection policy of the participating institutions.
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. No abstract available.
PubMed 31912792Di 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.
PubMed 35406516Tanaka 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.
PubMed 34559138Lemos 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.
PubMed 37701138
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Cohort for Investigating the Pathophysiology of Gastric MALT Lymphoma
- ClinicalTrials.gov ID
- NCT06454149
- Acronym / sponsor ID
- HUG-MALToma / HUG-MALToma
- Conditions
- Gastric MALT Lymphoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Kangbuk Samsung Hospital, Korea University Ansan Hospital
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 5 Jun 2028 (estimated)
- Study completion
- 5 Jun 2031 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MALT lymphoma | – | Other: MALT lymphomaPatients who were 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients who visited participating hospital will be asked, and upon providing informed consent, will be enrolled in the study.
Key inclusion criteria (6 listed)
- [MALT lymphoma group]
- Newly diagnosed as gastric MALT lymphoma [Control group]
- Patients who underwent
Key exclusion criteria (3 listed)
- History of gastric or other malignancy
- Use of antibiotics or probiotics within 4 weeks
- Uncontrolled chronic illnesses
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MALT lymphomaNew diagnosis with gastric MALT lymphoma | Other | MALT lymphoma |
Primary outcome
Remission of gastric MALT lymphoma
Time frame: Within 3 years from diagnosis
Remission of gastric MALT lymphoma
1 secondary outcome
Eradication of H. pylori infection
Time frame: Within 6 month from eradication therapy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Background: PubMed 31912792Zucca 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.
- Background: PubMed 35406516Di 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.
- Background: PubMed 34559138Tanaka 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.
- Background: PubMed 37701138Lemos 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.
- Individual participant dataSharing planned: No. IPD will not be shared due to data protection policy of the participating institutions.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastric MALT Lymphoma, run by Seoul National University Hospital at 3 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission of gastric MALT lymphoma (time frame: Within 3 years from diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06454149, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.