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The Clinical Study of Assessing HER-2 Expression in Gastric Cancer With Extra Tumor Tissue Paraffin Blocks Using Immunohistochemistry

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ClinicalTrials.gov Identifier: NCT02843412
Recruitment Status : Unknown
Verified July 2016 by Shanghai Zhongshan Hospital.
Recruitment status was:  Not yet recruiting
First Posted : July 25, 2016
Last Update Posted : July 25, 2016
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Brief Summary:

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.


Condition or disease Intervention/treatment
Gastric Cancer Surgical Specimens,18-80 Years Old, at Least Two Tumor Tissue Blocks Procedure: choose two tumor tissue paraffin blocks

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : August 2016
Estimated Primary Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Stomach Cancer
Drug Information available for: Paraffin

Group/Cohort Intervention/treatment
group 1
choose one tumor tissue paraffin blocks
group 2
choose two tumor tissue paraffin blocks
Procedure: choose two tumor tissue paraffin blocks



Primary Outcome Measures :
  1. compare the positive rate [ Time Frame: 3 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Undergone curative surgery of gastric cancer, 18-80 years old
Criteria

Inclusion Criteria:

  • Undergone curative surgery of gastric cancer,
  • 18-80 years old.

Exclusion Criteria:

  • None
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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT02843412    
Other Study ID Numbers: 123
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: July 25, 2016
Last Verified: July 2016
Keywords provided by Shanghai Zhongshan Hospital:
Gastric cancer
Her2/neu
Dual paraffin blocks
Trastuzumab
Clinical Prospective Multicenter Cohort Study
Additional relevant MeSH terms:
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Stomach Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Stomach Diseases