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Trial record 157 of 348 for:    hepatitis b | Open Studies

Marginal Zone Lymphoma Cohort in Korea

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2016 by Dong-A University Hospital
Sponsor:
Information provided by (Responsible Party):
Sung Yong Oh, Dong-A University Hospital
ClinicalTrials.gov Identifier:
NCT02732236
First received: April 4, 2016
Last updated: NA
Last verified: April 2016
History: No changes posted
  Purpose
Marginal zone lymphoma is a rare of subtype of Non-Hodgkin Lymphoma. Because of its rarity, prospective clinical trial is difficult to conduct. Therefore we want to make prospective MZL patients' cohort for several observation study

Condition Intervention
Lymphoma, B-Cell, Marginal Zone
Other: Rituximab

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 5 Years
Official Title: Hepatitis B Virus Reactivation in Patients With Marginal Zone B-cell Lymphoma After Rituximab Containing Treatment: Consortium for Improving Survival of Lymphoma (CISL) Marginal Zone Lymphoma Cohort Study (MARCO)

Resource links provided by NLM:


Further study details as provided by Dong-A University Hospital:

Primary Outcome Measures:
  • Hepatitis B virus reactivation in patients with marginal zone B-cell lymphoma after rituximab containing treatment [ Time Frame: September 2018 ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: March 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Rituximab
    Cohort observation study
Detailed Description:

Marginal zone lymphoma (MZL) is a distinct subgroup of non-Hodgkin's lymphoma (NHL), which is typically characterized by an indolent clinical course and long survival duration. MZL is responsible for approximately 7~8% of all NHL. In Korea, MZL accounts for 21% of all B-cell lymphoma and is the second most frequent histologic subtype following diffuse large B-cell lymphoma. Annually, an estimated 500 patients are newly diagnosed with MZL. According to the previous large-scale analyses, MZL is usually a quiet indolent malignancy, which generally presents with limited stage of disease. Localized disease may be controlled with local treatment, and a high response rate can be achieved. Advanced MZL is associated with less favorable survival, and appears to be incurable with the currently available therapy. Transformation to large cell aggressive lymphoma may occur in the first recurrence or in subsequent relapses.

Because of its rarity, prospective clinical trial is difficult to conduct. Therefore we want to make prospective MZL patients' cohort for several observation study especially related with Rituximab use (ex, Hepatitis B virus (HBV) reactivation)

  Eligibility

Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The patients who is diagnosed as a marginal zone lymphoma- nodal MZL, marginal zone lymphoma of MALT type, splenic MZL
Criteria

Inclusion Criteria:

  • pathological confirmed marginal zone lymphoma
  • No history of chemotherapy
  • enable to routine staging w/u and sampling including HBV serology
  • informed consent

Exclusion Criteria:

  • mixed with other type lymphoma
  • refuse informed consent
  • co-existing cancer needed treatment
  • prior organ transplantation
  • accompany with immunodeficiency
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02732236

Contacts
Contact: Sung Yong Oh, MD, PhD +82-51-240-2808 drosy@dau.ac.kr

Locations
Korea, Republic of
Sung Yong Oh Recruiting
Busan, Korea, Republic of, 602-715
Contact: SUNG YONG OH, Professor       drosy@dau.ac.kr   
Sponsors and Collaborators
Dong-A University Hospital
Investigators
Principal Investigator: Sung Yong Oh Consortium for improving survival of lymphoma office
  More Information

Responsible Party: Sung Yong Oh, Associate professor, Dong-A University Hospital
ClinicalTrials.gov Identifier: NCT02732236     History of Changes
Other Study ID Numbers: CISL-12-07 
Study First Received: April 4, 2016
Last Updated: April 4, 2016
Health Authority: Korea: Food and Drug Administration
Korea: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: Yes
Plan Description: We will share collected data with participated investigators in Korea

Keywords provided by Dong-A University Hospital:
marginal zone lymphoma
Cohort
Rituximab
HBV

Additional relevant MeSH terms:
Lymphoma, B-Cell, Marginal Zone
Lymphoma, B-Cell
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Rituximab
Antineoplastic Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents

ClinicalTrials.gov processed this record on December 09, 2016