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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00822731
Recruitment Status : Completed
First Posted : January 14, 2009
Last Update Posted : May 23, 2012
Sponsor:
Information provided by (Responsible Party):
Kim, Seok Jin, 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.

Condition or disease Intervention/treatment
Lymphoma Drug: Chemotherapy with or without radiotherapy

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  (Clinical Trial)
Actual Enrollment : 953 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Development of a Predictive Model for Treatment Outcome and Treatment-related Morbidity in a Prospective Cohort Study of Patients With Lymphoma
Study Start Date : September 2008
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma
U.S. FDA Resources

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 Name: Chemotherapy:CHOP, RCHOP, (R)HyperCVAD



Primary Outcome Measures :
  1. all cause mortality [ Time Frame: 5 years ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00822731


Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Seok Jin Kim, MD, PhD Samsung Medical Center

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kim, Seok Jin, Associate Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00822731     History of Changes
Other Study ID Numbers: 2008-08-068
First Posted: January 14, 2009    Key Record Dates
Last Update Posted: May 23, 2012
Last Verified: May 2012

Keywords provided by Kim, Seok Jin, Samsung Medical Center:
Lymphoma
prognosis
morbidity

Additional relevant MeSH terms:
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases