First-line Antibiotic Therapy for Early-stage HP(+) Gastric Pure DLBCL

NCT02388581 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2016-03-25

No results posted yet for this study

Summary

Aims: A nationwide study to prospectively validate

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.

Conditions

  • Gastric Diffuse Large B-cell Lymphoma

Interventions

DRUG

Lansoprazole, Amoxicillin, Clarithromycin, Metronidazole

Anti-H. pylori Therapy

Sponsors & Collaborators

  • National Taiwan University Hospital

    collaborator OTHER
  • Mackay Memorial Hospital

    collaborator OTHER
  • China Medical University Hospital

    collaborator OTHER
  • Taichung Veterans General Hospital

    collaborator OTHER
  • Changhua Christian Hospital

    collaborator OTHER
  • National Cheng-Kung University Hospital

    collaborator OTHER
  • Chang Gung Memorial Hospital

    collaborator OTHER
  • Kaohsiung Medical University

    collaborator OTHER
  • National Health Research Institutes, Taiwan

    lead OTHER

Principal Investigators

  • Sung-Hsin Kuo, MD, PhD. · National Taiwan University Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2017-12-31
Completion
2024-12-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02388581 on ClinicalTrials.gov