A Multicenter, Non-interventional, Descriptive Study to Assess Assay Concordance of HER2 IHC Testing in Chinese Pan-tumor Patients
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Pan-tumor(NSCLC, GYN Cancers, BTC and UC). Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pan HER2: A Multicenter, Non-interventional, Descriptive Study to Assess Assay Concordance of HER2 IHC Testing in Chinese Pan-tumor Patients
Overview
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.
Detailed description
This is a multicenter, non-interventional, descriptive study which included about 2100 patients, a mixture of NSCLC, BTC, GYN cancers and UC, from 12 sites with confirmed diagnosis between 2023 Jan and 2025 Sep. This study includes two phases, which are enrollment phase and assessment phase.
In the enrollment phase, all sites will retrospectively collect about 2100 patients (NSCLC \~1,000; BTC \~500; GYN \~450; and UC \~150). Every patient will be tested for HER2 status by 4B5 in local labs. All HER2 results will be reviewed and aligned by a committee of three pathologists using GC algorithms. Based on HER2 results by HercepTest at central lab, patient will be selected for further evaluation in assessment phase.
In assessment phase, a total of 320 patients will be included and selected from enrollment phase to meet sample size requirement which is 80 patients with different HER2 expression level (each 20 cases for IHC 0/1+/2+/3+) in NSCLC, BTC, GYN cancers and UC cohorts.
In Part I Assay performance evaluation, tissue sample of every patient will be sectioned at least 15 slides and send to central labs for assays evaluation. Interpretation results will be reviewed and aligned by a committee of three pathologists using GC algorithms. Assays and performed platform details are listed below: Roche 4B5 in Ventana platform, MXB\\Zhongshan\\An Biping\\Amoy in Ventana (or Leica) platform (5 assays) v.s. HercepTest in Dako platform.
Part II Interpretation concordance evaluation: inter-obsever agreement will be evaluated based on scanned images. Specifically, the first 40 slides (each 10 for 0/1+/2+/3+, each 10 for four disease cohorts) will be selected and digitalized. 36 pathologists, 3 from each site, will be trained for GC interpretation algorithm before joining in the assessment. All slides will be interpreted by all pathologists.
Primary outcome measures
- NPA of HER2 IHC 3+ based on confusion matrix results betwee other assays(Roche 4B5\MXB\Zhongshan\An Biping\Amoy) and HercepTest [Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month]
- PPA of HER2 IHC 3+ based on confusion matrix results between other assays(Roche 4B5\MXB\Zhongshan\An Biping\Amoy) and HercepTest [Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month]
Secondary outcome measures (12)
- Inter-observer concordance in binary HER2 negative (IHC 0/1+/2+) and positive status (IHC3+); [Time frame: From first slides interpreted to Interpretation concordance evaluation end，up to approximately 6 month]
- Inter-observer concordance in binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+); [Time frame: From first slides interpreted to Interpretation concordance evaluation end，up to approximately 6 month]
- Inter-observer concordance in four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 [Time frame: From first slides interpreted to Interpretation concordance evaluation end，up to approximately 6 month]
- OPA of HER2 IHC 3+ based on confusion matrix results between other assays and HercepTest [Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month]
- Cohen's kappa of HER2 IHC 3+ based on confusion matrix results between other assays and HercepTest [Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month]
- NPA of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort [Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month]
- PPA of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort [Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month]
- OPA of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort [Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month]
- Cohen's kappa of binary HER2 (IHC 0/1+) v.s. HER2 (IHC 2+/3+), and four category HER2 IHC 3+ vs. IHC 2+ vs. IHC 1+ vs. IHC 0 based on confusion matrix results between other assay and HercepTest, overall and by disease cohort [Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month]
- NPA of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort [Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month]
- PPA of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort [Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month]
- OPA of HER2 IHC 2+/3+ (IHC 1+ in GYN cancers) based on confusion matrix results between other assay and HercepTest, overall and by disease cohort [Time frame: From the assessment phase start to the final slides interpreted，up to approximately 6 month]
Eligibility criteria
Inclusion criteria
- Patients must be at least 18 years of age
- 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+).
- 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 criteria
- Have a history of other cancers besides NSCLC, BTC, GYN cancers and UC.
- Specimens of patients that may affect interpretation evaluated by the researcher (e.g., frozen specimens, decalcified specimens, specimens with limited tumor content, etc.)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 14 centers
- Research Site — Beijing
- Research Site — Changsha
- Research Site — Chengdu
- Research Site — Guangzhou
- Research Site — Guangzhou
- Research Site — Haerbin
- Research Site — Jinan
- Research Site — Nantong
- … and 6 more centers
Identifiers
NCT: NCT07404202 · D9673L00020