- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT01877109
Samsung Medical Center-Lymphoma Cohort Study-II (SMC-LCS-II)
Prospective Observation Cohort Study of Malignant Lymphoma Patients
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
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
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
-
-
Seoul, Korea, Republikken
- Samsung Medical Center
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Kohorte
- Tidsperspektiver: Fremadrettet
Kohorter og interventioner
Gruppe / kohorte |
---|
Lymphoma
Lymphoma patients
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
All cause mortality
Tidsramme: 5 years
|
Disease and non-disease-related mortality including treatment-related death
|
5 years
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Treatment response
Tidsramme: 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 |
1 year
|
Rate of occurrence of toxicity
Tidsramme: 2 years from the start of the 1st therapy
|
Infectious complications and other toxicities
|
2 years from the start of the 1st therapy
|
Quality of life
Tidsramme: 5 years
|
Change of quality of life
|
5 years
|
Biomarker development
Tidsramme: 5 years
|
Biomarkers associated with treatment outcome
|
5 years
|
Samarbejdspartnere og efterforskere
Sponsor
Publikationer og nyttige links
Generelle publikationer
- 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.
- 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.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2011-11-056
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