Samsung Medical Center-Lymphoma Cohort Study (SMC-LCS)

May 22, 2012 updated by: Kim, Seok Jin, Samsung Medical Center

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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

Study Type

Interventional

Enrollment (Actual)

953

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lymphoma
patients diagnosed as lymphoma
Drug: Chemotherapy with or without radiotherapy
Treatment regimen will be determined by the sub-type of lymphoma
Other Names:
  • Chemotherapy:CHOP, RCHOP, (R)HyperCVAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
all cause mortality
Time Frame: 5 years
5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Treatment response
Time Frame: after completion of primary therapy
after completion of primary therapy
Rate of occurrence of toxicity
Time Frame: 2 years from the start of the 1st therapy
2 years from the start of the 1st therapy
Treatment-related morbidity
Time Frame: within 60 days from the previous therapy
within 60 days from the previous therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

December 30, 2008

First Submitted That Met QC Criteria

January 12, 2009

First Posted (Estimate)

January 14, 2009

Study Record Updates

Last Update Posted (Estimate)

May 23, 2012

Last Update Submitted That Met QC Criteria

May 22, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-08-068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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