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Study Topics
Glossary
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Sponsors and Collaborators: |
National Health Research Institutes, Taiwan National Taiwan University Hospital Tri-Service General Hospital Chang Gung Memorial Hospital China Medical University Hospital Changhua Christian Hospital Chi-Mei Foundation Hospital . |
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Information provided by: | National Health Research Institutes, Taiwan |
ClinicalTrials.gov Identifier: | NCT00327132 |
Condition | Intervention |
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Gastric MALT Lymphoma |
Drug: Omeprazole, Amoxicillin, Clarithromycin |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety Study |
Official Title: | Multicentre,Prospective Study of First-Line Antibiotic Therapy for Early-Stage Low-Grade and High-Grade Gastric Mucosa-Associated Lymphoid Tissue-Type Lymphoma and Potential Predicting Factor for Treatment Outcome |
Estimated Enrollment: | 90 |
Study Start Date: | July 2006 |
Estimated Study Completion Date: | December 2014 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
The patients must have histologically confirmed primary gastric MALT lymphoma with or without clustering large cells (extranodal marginal zone lymphoma, and diffuse large cell lymphoma with features of MALT by REAL/WHO classification, Harris NL et al. 1994).
1.1 The diagnosis of primary gastric lymphoma must fulfill the criteria of Dawson [38].
Patients must have documented H. pylori infection before treatment, which will be evaluated by the following tests: histology, rapid urease test (CLO-test), C-13 urease breath test and serology.
Patients must have either stage IE or IIE-1 disease, according to an adaptation of the Ann Abor staging system modified by Musshoff for primary extranodal lymphoma.
Exclusion Criteria:
Contact: Wei-lien Feng, RN,MSN | 886-2-8792-3311 ext 17644 | winnif@nhri.org.tw |
Taiwan | |
China Medical University Hospital | Recruiting |
Taichung, Taiwan, 40447 | |
Contact: Ya-Lin WU, B.S. 886-4-22052121 ext 5372 yalin@nhri.org.tw | |
Principal Investigator: Chang-Fang Chiu, M.D. | |
Kaohsiung Medical University Hospital | Recruiting |
Kaohsiung, Taiwan, 80708 | |
Contact: Wei Te-Chih, B.S 886-7-3121101 ext 6109 hemawei@nhri.org.tw | |
Principal Investigator: Wen-Ming Wang | |
Mackay Memorial Hospital | Recruiting |
Taipei, Taiwan, 104 | |
Contact: Mei-Wha Lee, B.S. 886-2-2543-3535 ext 3454 lmh@nhri.org.tw | |
Principal Investigator: Chan-En Wang, M.D. | |
Veterans General Hospital-Taipei | Recruiting |
Taipei, Taiwan, 112 | |
Contact: Hsueh-Pin Yu, B.S. 886-2-2871-2121 ext 2518 dhpyu@nhri.org.tw. | |
Principal Investigator: Tzeng Shing Chen, M.D., PHD | |
National Taiwan University Hospital | Recruiting |
Taipei, Taiwan, 115 | |
Contact: Ling-Fang Lin., B.S. 886-2-2312-3456 ext 7677 dale@nhri.org.tw | |
Principal Investigator: Chi-An Chen, M.D. | |
Tri-Services General Hospital | Recruiting |
Taipei, Taiwan, 11490 | |
Principal Investigator: Tsai Yuan Shieh, M.D, Ph.D | |
National Taiwan University Hospital | Recruiting |
Taipei, Taiwan, 112 | |
Contact: Bor-Rong Chen, B.S. 886-2-2312-3456 ext 7677 brong@nhri.org.tw | |
Principal Investigator: Li-Tzong chen, M.D. PhD |
Principal Investigator: | Jaw-Town , Lin, M.D., PHD | Taiwan cooperative oncology group |
Principal Investigator: | Li Tzong Chen, M.D., Ph.D. | Taiwan cooperative oncology group |
Study ID Numbers: | T3206 |
Study First Received: | May 17, 2006 |
Last Updated: | September 14, 2006 |
ClinicalTrials.gov Identifier: | NCT00327132 |
Health Authority: | Taiwan: Department of Health |
Early-stage Lg/Hg Gastric MALT Lymphoma Eradication of Helicobacter pylori (Hp) |
Lymphoma, B-Cell Clarithromycin Lymphatic Diseases Amoxicillin Immunoproliferative Disorders B-cell lymphomas |
Omeprazole Lymphoma, B-Cell, Marginal Zone Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Lymphoma |
Protein Synthesis Inhibitors Anti-Infective Agents Anti-Bacterial Agents Neoplasms Neoplasms by Histologic Type |
Molecular Mechanisms of Pharmacological Action Immune System Diseases Therapeutic Uses Enzyme Inhibitors Pharmacologic Actions |