UMIN ID: C000000347
Registered date:10/03/2006
Randomized controlled trial to compare CMV antigenemia assay and real-time PCR after unrelated bone marrow transplantation.
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Bone marrow transplant recipients. |
| Date of first enrollment | 2001/11/01 |
| Target sample size | 100 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | pre-emptive therapy based on antigenemia assay pre-emptive therapy based on real-time PCR |
Outcome(s)
| Primary Outcome | Incidence of CMV disease within 100 days after transplantation |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 55years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Life expectancy shorter than 3 months Both donor and recipient CMV negative Severe organ dysfunction or infection ECOG PS 2-4 |
Related Information
| Primary Sponsor | Ministry of Health, Labor and Welfare of Japan |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labor and Welfare of Japan |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Yoshinobu Kanda |
| Address | 7-3-1 Hongo, Bunkyo, Tokyo, Japan Japan |
| Telephone | 03-3815-5411 |
| ycanda-tky@umin.ac.jp | |
| Affiliation | University of Tokyo Hospital Department of Hematology & Oncology |
| scientific contact | |
| Name | Yoshinobu Kanda |
| Address | 7-3-1 Hongo, Bunkyo, Tokyo, Japan Japan |
| Telephone | 03-3815-5411 |
| Affiliation | University of Tokyo Hospital Department of Hematology & Oncology |