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Local solution / Reference solution / Lung Cancer · Observational Study
ClinicalTrials.gov · September 9, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a prospective, multi-center observational registry record for a two-stage study designed to assess concordance of TROP2 NMR testing across different laboratory solutions and real-world pathology sites in untreated advanced NSCLC. No results are yet reported in this registry entry; the study is currently recruiting. The protocol aims to evaluate reproducibility and robustness of a diagnostic test platform across laboratory conditions.
Observational. Lung Cancer; age from 18 Years. Intervention: The study is a cross-sectional study with no cohort design. Compared with: Reference solution serves as the comparator standard in Stage 1 and Stage 2.. n = 3,400. 4 sites: China.
This is a prospective, multi-center observational registry record for a two-stage study designed to assess concordance of TROP2 NMR testing across different laboratory solutions and real-world pathology sites in untreated advanced NSCLC. No results are yet reported in this registry entry; the study is currently recruiting. The protocol aims to evaluate reproducibility and robustness of a diagnostic test platform across laboratory conditions.
This is a registry record; no efficacy, safety, or concordance results are reported.
The source did not state who this applies to in practice.
This is a registry record for a planned observational study with no results reported; it describes study design and protocol only, making it preliminary evidence documentation rather than evidence of efficacy or safety.
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Quoted from the source exactly as published.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT07624318). This is a study registration, not published results. Lead sponsor: AstraZeneca. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 3400 participants (ESTIMATED). Conditions: Lung Cancer. Interventions: DEVICE: Reference solution; DEVICE: Mixed solution; DEVICE: Local solution. Primary outcome measures: Stage 1 - Solution concordance in central lab: To evaluate TROP2 NMR concordance between Local solution and Reference solution in the central lab , Approximately 6 months after collection of the first slide.; Stage2 - TROP2 NMR testing concordance among labs：To evaluate TROP2 NMR concordance of Reference solution between sites and central lab , Approximately 10 months after collection of the first slide.; Stage2 - TROP2 NMR testing concordance among labs：To evaluate TROP2 NMR concordance of Local solution in sites with Reference solution in central lab , Approximately 10 months after collection of the first slide.. Brief summary: This is a two-stage, multi-center study to compare concordance of Local solution and Mixed solution with a Reference solution in testing TROP2 NMR in untreated advanced NSCLC patients, as well as clinical application and robustness in real world labs. TROP2 NMR testing by QCS is composed of three main components: IHC assay, digital scanner and QCS algorithm. This study mainly focuses on end-to-end comparisons from different solutions or real-world labs. TROP2 NMR status results will be compared and the end-to-end concordance between solutions or labs will be assessed by PPA, NPA, and OPA. Three different solutions will be included in this study: Reference solution\\Local solution\\Mixed solution. Stage 1 will evaluate concordance of Local solution and Mixed solution with Reference solution in a central lab. Totally about 600 samples will be tested using Local solution, Mixed solution and Reference solution. When solutions concordance in stage 1 is achieved, the study will proceed to stage 2. Stage 2 will then assess the robustness and reproducibility of different solutions in real world pathology labs. About 1,000 TROP2 NMR positive (TROP2 NMR+) and 1,000 TROP2 NMR negative (TROP2 NMR-) samples will be identified by central lab using Reference solution, then these status-known samples will be distributed to approximately 50 participating site labs with 20 TROP2 NMR+ and 20 TROP2 NMR- per site, and subsequently tested at site labs in a blinded manner using Reference solution, and/or Local solution and/or Mixed solution, depending on Stage 1 results.
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