Samsung Medical Center-Lymphoma Cohort Study

Lymphoma Clinical Trial

— SMC-LCS  

Official title:

Development of a Predictive Model for Treatment Outcome and Treatment-related Morbidity in a Prospective Cohort Study of Patients With Lymphoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00822731
• Other study ID #: 2008-08-068
• Status: Completed
• Phase: N/A
• First received: December 30, 2008
• Last updated: May 22, 2012
• Start date: September 2008
• Est. completion date: December 2011

Study information

• Verified date: May 2012
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

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 following factors which amy probably 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: 953
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Patients who were diagnosed as lymphoma

• Over 15 years old

• Patients who agreed the enrollment of study

• Informed consent for sampling

Exclusion Criteria:

• Patients who do not want to join the study

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Lymphoma

Intervention

Drug:
• Chemotherapy with or without radiotherapy
Treatment regimen will be determined by the sub-type of 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		5 years	No
Secondary	Treatment response		after completion of primary therapy	No
Secondary	Rate of occurrence of toxicity		2 years from the start of the 1st therapy	No
Secondary	Treatment-related morbidity		within 60 days from the previous therapy	No