Samsung Medical Center-Lymphoma Cohort Study-II

Lymphoma Clinical Trial

— SMC-LCS-II  

Official title:

Prospective Observation Cohort Study of Malignant Lymphoma Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01877109
• Other study ID #: 2011-11-056
• Status: Completed
• Phase: N/A
• First received: June 3, 2013
• Last updated: October 25, 2017
• Start date: February 1, 2012
• Est. completion date: February 28, 2017

Study information

• Verified date: October 2017
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1358
• Est. completion date: February 28, 2017
• Est. primary completion date: February 28, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Patients who were diagnosed as lymphoma

• Over 19 years old

• Patients who agreed the enrollment of study

• Informed consent for sampling

Exclusion Criteria:

•Patients who do not want to join the study

Related Conditions & MeSH terms

• Lymphoma

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause mortality	Disease and non-disease-related mortality including treatment-related death	5 years
Secondary	Treatment response	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	1 year
Secondary	Rate of occurrence of toxicity	Infectious complications and other toxicities	2 years from the start of the 1st therapy
Secondary	Quality of life	Change of quality of life	5 years
Secondary	Biomarker development	Biomarkers associated with treatment outcome	5 years