First-line Antibiotic Therapy for Early-stage HP(+) Gastric Pure DLBCL
NCT ID: NCT02388581
Last Updated: 2016-03-25
Study Results
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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UNKNOWN
PHASE2
30 participants
INTERVENTIONAL
2014-12-31
2024-12-31
Brief Summary
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1. The complete histological and molecular remission rate for antibiotics as 1st-line therapy for early-stage Hp-positive gastric pure (de novo) DLBCL
2. The durability of complete histological remission after antibiotics
3. The usefulness of pattern of NF-kB, BCL10, BAFF, and CagA by IHC staining in prospectively predicting the Hp-dependence of gastric pure (de novo) DLBCL
4. The frequency of t(11;18)(q21;q21) translocation in gastric pure (de novo) DLBCL in Taiwan.
5. The association between the CYP2C18/CYP2C19 genetic polymorphisms and eradication of Hp infection after antibiotics.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Anti-H. pylori Therapy
Lansoprazole, Amoxicillin, Clarithromycin, Metronidazole
Lansoprazole, Amoxicillin, Clarithromycin, Metronidazole
Anti-H. pylori Therapy
Interventions
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Lansoprazole, Amoxicillin, Clarithromycin, Metronidazole
Anti-H. pylori Therapy
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient must have no prior chemotherapy or radiotherapy for his/her gastric pure (de novo) gastric DLBCL.
3. Patients must have evaluable disease by endoscopy and/or by computed tomography.
4. Patients must have documented H. pylori infection before treatment, if any of the following test show positive result: histology, rapid urease test (CLO-test), C13 urease breath test, and serology.
5. Patients must have either stage IE or IIE-1 disease, according to an adaptation of the Ann Arbor staging system modified by Musshoff for primary extranodal lymphoma.
6. Patients who are either newly diagnosed or already starting anti-H. pylori therapy but not have follow-up endoscopy and biopsy are eligible.
7. Patient must have signed the informed consent, and agree to provide achieved pathologic material for immunohistochemical / fluorescence in situ hybridization study and RT-PCR for t(11;18)(q21;q21) determination.
Exclusion Criteria
2. Patients with previous history of extranodal lymphoma.
3. Patients with stage IIE-2 or beyond disease: infiltration of regional lymph node.
4. Patients with cardiopulmonary status that do not allow repeat endoscopy.
5. Patients with prior chemotherapy or radiotherapy for their primary gastric lymphoma.
6. Patients who had previous anti-H. pylori therapy and without pretreatment pathology achieve material for histological review and immunohistochemical study.
ALL
No
Sponsors
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National Taiwan University Hospital
OTHER
Mackay Memorial Hospital
OTHER
China Medical University Hospital
OTHER
Taichung Veterans General Hospital
OTHER
Changhua Christian Hospital
OTHER
National Cheng-Kung University Hospital
OTHER
Chang Gung Memorial Hospital
OTHER
Kaohsiung Medical University
OTHER
National Health Research Institutes, Taiwan
OTHER
Responsible Party
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Principal Investigators
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Sung-Hsin Kuo, MD, PhD.
Role: PRINCIPAL_INVESTIGATOR
National Taiwan University Hospital
Locations
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National Health Research Institutes
Zhunan, Miaoli County, Taiwan
Countries
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Central Contacts
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Other Identifiers
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T2214
Identifier Type: -
Identifier Source: org_study_id
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