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Completed

NCT Number: NCT01877109

Samsung Medical Center-Lymphoma Cohort Study-II

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.

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsung Medical Center

Seoul, South Korea

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. All cause mortality

    Time frame: 5 years

    Disease and non-disease-related mortality including treatment-related death

Secondary outcomes

  1. Treatment response

    Time frame: 1 year

    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

  2. Rate of occurrence of toxicity

    Time frame: 2 years from the start of the 1st therapy

    Infectious complications and other toxicities

  3. Quality of life

    Time frame: 5 years

    Change of quality of life

  4. Biomarker development

    Time frame: 5 years

    Biomarkers associated with treatment outcome

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

Prospective Observation Cohort Study of Malignant Lymphoma Patients

Acronym: SMC-LCS-II

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jun 13, 2013
Registry last updated
Oct 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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