NCT07404202 A Multicenter, Non-interventional, Descriptive Study to Assess Assay Concordance of HER2 IHC Testing in Chinese Pan-tumor Patients
| NCT ID | NCT07404202 |
| Status | Recruiting |
| Phase | — |
| Sponsor | AstraZeneca |
| Condition | Pan-tumor(NSCLC, GYN Cancers, BTC and UC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,100 participants |
| Start Date | 2026-03-06 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,100 participants in total. It began in 2026-03-06 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07404202 clinical trial?
This trial is open to participants of all sexes, studying Pan-tumor(NSCLC, GYN Cancers, BTC and UC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07404202 currently recruiting?
Yes, NCT07404202 is actively recruiting participants. Contact the research team at information.center@astrazeneca.com for enrollment information.
Where is the NCT07404202 trial being conducted?
This trial is being conducted at Beijing, China, Changsha, China, Chengdu, China, Guangzhou, China and 10 additional locations.
Who is sponsoring the NCT07404202 clinical trial?
NCT07404202 is sponsored by AstraZeneca. The trial plans to enroll 2,100 participants.
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