Gastric Cancer Surgical Specimens,18-80 Years Old, at Least Two Tumor Tissue Blocks Clinical Trial
| NCT number | NCT02843412 |
| Other study ID # | 123 |
| Secondary ID | |
| Status | Not yet recruiting |
| Phase | N/A |
| First received | July 21, 2016 |
| Last updated | July 22, 2016 |
| Start date | August 2016 |
Background: Gastric cancer (GC) is major global health concern and the second leading cause
of cancer deaths worldwide. Amplification of Her2/neu gene and/or overexpression of the
Her2/neu protein have been observed in GC. Trastuzumab (Herceptin™) is an anti-Her2/neu
antibody, which has been successfully applied in GC. However, the intratumoral heterogeneity
of Her2/neu overexpression and amplification in GC should be noticed. The investigators
investigated the significance of evaluating Her2/neu expression in different paraffin blocks
of tumor tissue in GC.
Methods: 2000 GC patients from ten centers, patients were divided into a cohort using one
tumor tissue paraffin block (cohort 1, n=1000) and a cohort using dual tumor tissue paraffin
blocks (cohort 2, n=1000) when evaluating Her2/neu expression status by immunohistochemistry
(IHC). In cohort 2, the investigators combined the results from two different paraffin
blocks and used the higher one as the final score.
| Status | Not yet recruiting |
| Enrollment | 2000 |
| Est. completion date | |
| Est. primary completion date | May 2018 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Undergone curative surgery of gastric cancer, - 18-80 years old. Exclusion Criteria: |
Observational Model: Cohort, Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai Zhongshan Hospital |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | compare the positive rate | 3 years | No |