UMIN ID: C000000059
Registered date:15/08/2005
Evaluation of feasibility and accuracy of diagnosis using sentinel node biopsy in early gastric cancer(JCOG0302, GCSSG-SNB)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | gastric neoplasm |
| Date of first enrollment | 2004/05/01 |
| Target sample size | 1550 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Gastrectomy with extemded lymphadenectomy after sentinel node biopsy |
Outcome(s)
| Primary Outcome | False-negative rate |
|---|---|
| Secondary Outcome | Success rate, false-positive rate, post-operative morbidity, anaphylaxis reaction, relapse-free survival of patients with lymph node metastases |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | 80years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | (1) anaphylaxis reaction against iodine, (2) non-curative synchronous malignancy. |
Related Information
| Primary Sponsor | Japan Clinical Oncology Group(JCOG) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Isao Miyashiro, MD, PhD |
| Address | 1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, JAPAN Japan |
| Telephone | |
| JCOG_sir@ml.jcog.jp | |
| Affiliation | JCOG0302 Coordinating Office Gastric Surgery Division, Osaka Medical Center for Cancer and Cardiovascular Diseases |
| scientific contact | |
| Name | Masahiro Hiratsuka, MD, PhD |
| Address | 1-100 Koyaike, Itami, Hyogo 664-8540, JAPAN Japan |
| Telephone | |
| Affiliation | Itami municipal hospital Surgery |