Status:
NOT_YET_RECRUITING
Prospective Study of Frontline Antibiotics Therapy in the Treatment of Early-stage HP-negative Gastric MALT Lymphoma
Lead Sponsor:
National Taiwan University Hospital
Conditions:
MALT Lymphoma of Stomach
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
We hypothesized that a proportion of patients with localized Helicobacter pylori-negative gastric MALT lymphoma may well respond to frontline Helicobacter pylori eradication therapy (HPE) and remain l...
Detailed Description
Gastric mucosa-associated lymphoid tissue (MALT) lymphoma (marginal zone B-cell lymphoma) is the most common extranodal MALT lymphoma. Since the association between Helicobacter pylori (HP) infection ...
Eligibility Criteria
Inclusion
- The patients must have histologically confirmed primary gastric MALT lymphoma by REAL/WHO classification
- The patient must have no prior chemotherapy or radiotherapy for his/her gastric MALT lymphoma
- Patients must have evaluable disease by endoscopy and/or the nodal status by computed tomography 3.1 If patients have endoscopic lesions without computed tomography-demonstrating lesions are eligible.
- 2 Endoscopic ultrasonography (EUS) is optional to evaluate the depth of tumor infiltration and for status of perigastric lymph node enlargement
- Patients must have documented to have no HP infection before treatment, which will be evaluated by the following tests: histology, rapid urease test (CLO-test), C-13 urease breath test, HP stool antigen, and serology; and all of the five tests have to be negative for the diagnosis of no evidence of HP infection.
- Patients must have either stage IE or IIE1 disease, according to an adaptation of the Ann Arbor staging system modified by Musshoff for primary extranodal lymphoma.
- Patients must have signed the informed consent and agree to provide achieved pathologic material and tumor biopsy for translational study
- Patients must have signed the informed consent and agree to provide achieved blood samples for potential serum molecular studies and fecal samples for researches of gut microbiota
Exclusion
- Active second malignancies during the last five years except non melanomatous skin cancer, carcinoma in situ of cervix, lobular or ductal carcinoma in situ of breast.
- Patients with previous history of extranodal lymphoma are not eligible.
- Patients with stage IIE2 or beyond disease: infiltration of regional lymph nodes not adjacent primary involved site.
- Patients with cardiopulmonary status that do not allow repeat examination are not eligible.
- Patients with prior chemo- or radiotherapy for their extragastric lymphoma are not eligible.
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07144657
Start Date
September 1 2025
End Date
December 31 2030
Last Update
August 27 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
National Taiwan University Hospital
Taipei, None Selected, Taiwan, 100