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Status unknownNCT02843412Updated Jul 25, 2016

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

An observational study in Gastric Cancer Surgical Specimens,18-80 Years Old, at Least Two Tumor Tissue Blocks, sponsored by Shanghai Zhongshan Hospital. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2016-07-25.

Sponsored by Shanghai Zhongshan Hospital · Observational

The sponsor has not verified this record recently (last verified Jul 2016), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
2,000
Ages
18 Years to 80 Years
Sex
All
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Study 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.

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Conditions studied

  • Gastric Cancer Surgical Specimens,18-80 Years Old, at Least Two Tumor Tissue Blocks

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Keywords

  • Gastric cancer
  • Her2/neu
  • Dual paraffin blocks
  • Trastuzumab
  • Clinical Prospective Multicenter Cohort Study
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In context

Stomach Neoplasms

2,851 studies on the registry are indexed under Stomach Neoplasms; 864 are open to participants now.

This study's planned enrollment of 2,000 is above the median of 274 across 670 observational studies indexed under Stomach Neoplasms.

Browse Stomach Neoplasms studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 636 studies on the registry; 283 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • None
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
2,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • group 1

    choose one tumor tissue paraffin blocks

  • group 2

    choose two tumor tissue paraffin blocks

    Procedure: choose two tumor tissue paraffin blocks

Interventions

  • Procedurechoose two tumor tissue paraffin blocks
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What researchers measure

Primary outcomes

  1. compare the positive rate

    Time frame: 3 years

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • Xu C, Sun M, Jin M, Li Z, Qin R, Ren G, Sun W, Chen L, Luan L, Liu Y, Jiang D, Chen L, Luo R, Hou Y. Dual block HER2 assessment increased HER2 immunohistochemistry positive rate in resected specimens of gastric cancer: a prospective multicenter clinical trial from China. Diagn Pathol. 2022 Jun 28;17(1):54. doi: 10.1186/s13000-022-01230-7. PubMed 35765007 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02843412
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Sponsor
First posted
Jul 25, 2016
Start date
Aug 2016
Primary completion
May 2018 (estimated)
Last update
Jul 25, 2016
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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