Cohort Study for Gastric MALT Lymphoma

NCT ID: NCT06454149

Last Updated: 2024-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-06-06

Study Completion Date

2031-06-05

Brief Summary

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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).

Detailed Description

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Conditions

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Gastric MALT Lymphoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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MALT lymphoma

Patients who were newly diagnosed as gastric MALT lymphoma

MALT lymphoma

Intervention Type OTHER

New diagnosis with 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.

No interventions assigned to this group

Interventions

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MALT lymphoma

New diagnosis with gastric MALT lymphoma

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Kangbuk Samsung Hospital

OTHER

Sponsor Role collaborator

Korea University Ansan Hospital

OTHER

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Cheol Min Shin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Korea University Ansan Hospital

Ansan-si, Gyeonggi-do, South Korea

Site Status NOT_YET_RECRUITING

Cheol Min Shin

Seongnam-si, Gyeonggi-do, South Korea

Site Status RECRUITING

Kangbuk Samsung Hospital

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Facility Contacts

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Ayoung Lee, MD. PhD.

Role: primary

82-31-412-5114

Cheol Min Shin, M.D., Ph.D.

Role: primary

+ 82-31-787-7057

Hyo-Joon Yang, MD. PhD.

Role: primary

82-2-2001-8330

References

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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: [email protected]. 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.

Reference Type BACKGROUND
PMID: 31912792 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35406516 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 34559138 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37701138 (View on PubMed)

Other Identifiers

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HUG-MALToma

Identifier Type: -

Identifier Source: org_study_id

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