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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kim, Seok Jin, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00822731
First received: December 30, 2008
Last updated: May 22, 2012
Last verified: May 2012
  Purpose

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 Intervention
Lymphoma
Drug: Chemotherapy with or without radiotherapy

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • all cause mortality [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Treatment response [ Time Frame: after completion of primary therapy ] [ Designated as safety issue: No ]
  • Rate of occurrence of toxicity [ Time Frame: 2 years from the start of the 1st therapy ] [ Designated as safety issue: No ]
  • Treatment-related morbidity [ Time Frame: within 60 days from the previous therapy ] [ Designated as safety issue: No ]

Enrollment: 953
Study Start Date: September 2008
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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
  Eligibility

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided by Samsung Medical Center

Additional 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
Study First Received: December 30, 2008
Last Updated: May 22, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by 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

ClinicalTrials.gov processed this record on April 17, 2014