Comparing HER2 Test Results on Tumor Samples From Chinese Patients With Several Cancers
Compares HER2 test results on stored tumor samples from Chinese cancer patients.
Plain-language title generated from the registry record
Registry title: A Multicenter, Non-interventional, Descriptive Study to Assess Assay Concordance of HER2 IHC Testing in Chinese Pan-tumor Patients
Key facts
- Where
- Beijing, Changsha, Chengdu, Guangzhou, Haerbin, Jinan, Nantong, Shanghai, Shenyang, Suzhou, Ürümqi, and Zhejiang, ChinaSee the 12 sites
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with a confirmed diagnosis of lung cancer (NSCLC), biliary tract cancer, gynecological cancer or urothelial cancer, who have enough stored tumor tissue for HER2 testing.
- Age
- 18 years or older
- Sex
- Men and women
- Disease stage
- Confirmed diagnosis of NSCLC, BTC, GYN cancers (only cervical, endometrial or ovarian cancer) or UC, made between Jan 01, 2023 and Sep 30, 2025.
- Biomarker or test result
- HER2 status is determined on stored tumor tissue (IHC 0/1+/2+/3+). For each gynecological cancer type, at least 5 cases are needed at each expression level.
Main reasons for not taking part
- A history of other cancers besides NSCLC, BTC, GYN cancers and UC
- Tissue samples that could affect interpretation, such as frozen samples, decalcified samples or samples with limited tumor content
Read by machine on 9 November 2026.
Where in China
- BeijingBeijing, ChinaTaking people
- ChangshaChangsha, ChinaNo longer taking part
- ChengduChengdu, ChinaNo longer taking part
- GuangzhouGuangzhou, ChinaNo longer taking part
- HaerbinHaerbin, ChinaNo longer taking part
- JinanJinan, ChinaNo longer taking part
- NantongNantong, ChinaNo longer taking part
- ShanghaiShanghai, ChinaNo longer taking part
- ShenyangShenyang, ChinaNo longer taking part
- SuzhouSuzhou, ChinaNo longer taking part
- ÜrümqiÜrümqi, ChinaNo longer taking part
- ZhejiangZhejiang, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AstraZeneca
- Trial code
- NCT07404202
- Record updated
- 28 October 2026
- Original description
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.Read full original descriptionShow less
Pan HER2: A Multicenter, Non-interventional, Descriptive Study to Assess Assay Concordance of HER2 IHC Testing in Chinese Pan-tumor Patients
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.
Inclusion: 1. Patients must be at least 18 years of age; 2. Male and female patients must have a histological confirmed diagnosis of NSCLC, BTC, GYN cancers, or UC between Jan 01, 2023 and Sep 30, 2025; --For GYN cancers, only cervical cancer, endometrial cancer and ovarian cancer should be included. For each gynecological cancer listed above, at least 5 cases need to be enrolled at each expression level (i.e., IHC 0/1+/2+/3+); 3. Patients must have sufficient archived tumor tissue available, with at least 15 slides suitable for HER2 status determination. Both resection or biopsy samples are acceptable. The age limit of archived tissue blocks is 5 years.
Exclusion: 1. Have a history of other cancers besides NSCLC, BTC, GYN cancers and UC; 2. Specimens of patients that may affect interpretation evaluated by the researcher (e.g., frozen specimens, decalcified specimens, specimens with limited tumor content, etc.).