Samsung Medical Center-Lymphoma Cohort Study-II

Completed

• Conditions: Lymphoma

• Registration Number: NCT01877109
• Lead Sponsor: Samsung Medical Center

Brief Summary

The purpose of this study is to establish a model which can predict the treatment outcome and the risk of treatment-related morbidity in patients with lymphoma.

Detailed Description

Although the cure rate of lymphoma has been increased due to the development of newer effective drugs, a substantial portion of patients is still suffered from relapse. Furthermore, the treatment-related morbidity is another factor which can make the treatment outcome worse in patients with lymphoma, especially elderly patients. Thus, this study is going to assess factors which may affect the treatment outcome and the risk of treatment-related morbidity.

1.Biologic factors associated with the aggressiveness of lymphoma

* molecular markers in serum, cytogenetic markers 2.Factors associated with the risk of treatment-related morbidity

* comorbidity, nutrition status, performance status, quality of life at diagnosis

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2012-02-01
• Study First Submitted: 2013-06-03
• Study First Submitted QC: 2013-06-10
• Study First Posted: 2013-06-13
• Primary Completion: 2017-02-28
• Study Completion: 2017-02-28
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-25
• Last Update Posted: 2017-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1358

Inclusion Criteria

• Patients who were diagnosed as lymphoma
• Over 19 years old
• Patients who agreed the enrollment of study
• Informed consent for sampling

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Exclusion Criteria

•Patients who do not want to join the study

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
All cause mortality	5 years	Disease and non-disease-related mortality including treatment-related death

Secondary Outcome Measures

Name	Time	Method
Rate of occurrence of toxicity	2 years from the start of the 1st therapy	Infectious complications and other toxicities
Biomarker development	5 years	Biomarkers associated with treatment outcome
Treatment response	1 year	Response to primary and salvage treatment Revised response criteria for lymphoma should be used (J Clin Oncol 2007;25(5):579-586).; Complete response: disappearance of all evidence of disease Partial response: regression of measurable disease and no new sites Stable disease: failure to attain CR/PR or PD Relapsed disease or Progressive disease: Any new lesion or increase by \>=50% of previously involved sites from nadir
Quality of life	5 years	Change of quality of life

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of