UMIN ID: UMIN000000741
Registered date:18/06/2007
Quantification of Epstein-Barr virus DNA in patients undergoing SMILE chemotherapy for stage IV or relapsed/refractory extranodal NK/T-cell lymphoma
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | untreated stage IV or relapsed/refractory NK/T-cell lymphoma |
| Date of first enrollment | 2007/07/01 |
| Target sample size | 28 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | SMILE chemotherapy (steroid, methotrexated, ifosfamide, l-asparaginase, etoposide) |
Outcome(s)
| Primary Outcome | Disappearance rate of EBV-DNA after two cycles of the SMILE quantified by whole blood method |
|---|---|
| Secondary Outcome | Disapperance rate of EBV-DNA after completion of intended therapy, prognostic value of EBV-DNA level, comparison between two methods of EBV-DNA quantification (whole blood vs plasma) |
Key inclusion & exclusion criteria
| Age minimum | 15years-old |
|---|---|
| Age maximum | 69years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | none |
Related Information
| Primary Sponsor | NK-cell Tumor Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Grant-in-aid of Ministry of Health, Labour and Welfare (Cancer Research), "International clinical study for NK-cell tumor among the East Asia". |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Ritsuro Suzuki |
| Address | Japan |
| Telephone | |
| r-suzuki@med.nagoya-u.ac.jp | |
| Affiliation | Nagoya University School of Medicine Department of HSCT Data Management |
| scientific contact | |
| Name | Kazuo Oshimi |
| Address | 2-1-1 Hongo, Bunkyo-ku, Tokyo 113-8421, Japan Japan |
| Telephone | |
| Affiliation | Juntendo University School of Medicine Department of Hematology |