Clinical trial NCT00822731: Samsung Medical Center-Lymphoma Cohort Study
Official title: Development of a Predictive Model for Treatment Outcome and Treatment-related Morbidity in a Prospective Cohort Study of Patients With Lymphoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lymphoma
Keywords: Lymphoma
prognosis
morbidity
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2009-01-14
Enrollment: 953
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

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 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

Primary outcomes:
measure: all cause mortality
timeFrame: 5 years
Secondary outcomes:
measure: Treatment response
timeFrame: after completion of primary therapy
measure: Rate of occurrence of toxicity
timeFrame: 2 years from the start of the 1st therapy
measure: Treatment-related morbidity
timeFrame: within 60 days from the previous therapy
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Seok Jin Kim, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cho I, Lee H, Yoon SE, Ryu KJ, Ko YH, Kim WS, Kim SJ. Serum levels of soluble programmed death-ligand 1 (sPD-L1) in patients with primary central nervous system diffuse large B-cell lymphoma. BMC Cancer. 2020 Feb 13;20(1):120. doi: 10.1186/s12885-020-6612-2.
citation: Kim SJ, Hong M, Do IG, Lee SH, Ryu KJ, Yoo HY, Hong JY, Ko YH, Kim WS. Serum survivin and vascular endothelial growth factor in extranodal NK/T-cell lymphoma, nasal type: implications for a potential new prognostic indicator. Haematologica. 2015 Mar;100(3):e106-9. doi: 10.3324/haematol.2014.116087. Epub 2014 Dec 5. No abstract available.
citation: Hong JY, Yoon DH, Suh C, Huh J, Do IG, Sohn I, Jo J, Jung SH, Hong ME, Yoon H, Ko YH, Kim SJ, Kim WS. EBV-positive diffuse large B-cell lymphoma in young adults: is this a distinct disease entity? Ann Oncol. 2015 Mar;26(3):548-55. doi: 10.1093/annonc/mdu556. Epub 2014 Dec 4.
citation: Jung HA, Park S, Cho JH, Kim S, Ko YH, Kim SJ, Kim WS. Prognostic relevance of pretreatment quality of life in diffuse large B-cell lymphoma patients treated with rituximab-CHOP: results from a prospective cohort study. Ann Hematol. 2012 Nov;91(11):1747-56. doi: 10.1007/s00277-012-1516-0. Epub 2012 Jun 28.