UMIN ID: UMIN000002209
Registered date:17/07/2009
Blood-based Early Detection Tests for Gastric Cancer Program, Pilot Clinical Study (Phase I)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Gastric Cancer |
| Date of first enrollment | 2009/08/01 |
| Target sample size | 250 |
| Countries of recruitment | Japan |
| Study type | Observational |
| Intervention(s) |
Outcome(s)
| Primary Outcome | Sensitivity and specificity of biomarhkers |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Subject was taking experimental drug or anticancer drug within the past 30 days. Subject has been confirmed as having cancer in the past. Subject was confirmed as having cancer excluding gastric cancer at present. Major trauma or surgery within the past 3 months before study procedure. Subject is considered by the investigator to be an unsuitable candidate for this study. Known or suspected infection with human immunodeficiency virus or infectious hepatitis. |
Related Information
| Primary Sponsor | Alere San Diego Inc. |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Alere San Diego Inc. |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Masahiro Sakabe |
| Address | 18F STEC Jyoho Building 1-24-1 Nishi-Shinjuku Shinjuku-ku, Tokyo 160-0023 Japan Japan |
| Telephone | |
| Affiliation | Alere Medical Co., Ltd. Technical Support |
| scientific contact | |
| Name | Toshiharu Yamaguchi |
| Address | 3-8-31 Ariake Kohtoh-ku Tokyo 135-8550, Japan Japan |
| Telephone | |
| Affiliation | Cancer Institute Ariake Hospital Gastroenterological Center |