Actively Recruiting
A Multicenter, Non-interventional, Descriptive Study to Assess Assay Concordance of HER2 IHC Testing in Chinese Pan-tumor Patients
Led by AstraZeneca · Updated on 2026-04-22
2100
Participants Needed
14
Research Sites
42 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, non-interventional, descriptive study to retrospectively collect solid tumor samples from focused tumor types (NSCLC, GYN cancers, BTC and UC) and assess both assay concordance and interpretation concordance.
CONDITIONS
Official Title
A Multicenter, Non-interventional, Descriptive Study to Assess Assay Concordance of HER2 IHC Testing in Chinese Pan-tumor Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must be at least 18 years of age
- Male and female patients must have a histologically confirmed diagnosis of NSCLC, BTC, GYN cancers (cervical, endometrial, ovarian), or UC between Jan 01, 2023 and Sep 30, 2025
- For each gynecological cancer type, at least 5 cases must be enrolled at each HER2 expression level (IHC 0/1+/2+/3+)
- Patients must have sufficient archived tumor tissue with at least 15 slides suitable for HER2 status determination
- Archived tissue blocks must be no older than 5 years
- Both resection or biopsy samples are acceptable
You will not qualify if you...
- History of cancers other than NSCLC, BTC, GYN cancers, and UC
- Specimens that may affect test interpretation, such as frozen specimens, decalcified specimens, or those with limited tumor content
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 14 locations
1
Research Site
Beijing, China
Actively Recruiting
2
Research Site
Changsha, China
Withdrawn
3
Research Site
Chengdu, China
Actively Recruiting
4
Research Site
Guangzhou, China
Actively Recruiting
5
Research Site
Guangzhou, China
Withdrawn
6
Research Site
Guangzhou, China
Not Yet Recruiting
7
Research Site
Haerbin, China
Actively Recruiting
8
Research Site
Jinan, China
Actively Recruiting
9
Research Site
Nantong, China
Actively Recruiting
10
Research Site
Shanghai, China
Not Yet Recruiting
11
Research Site
Shanghai, China
Actively Recruiting
12
Research Site
Shenyang, China
Not Yet Recruiting
13
Research Site
Suzhou, China
Withdrawn
14
Research Site
Ürümqi, China
Not Yet Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
4
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