Clinical trial · Observational
Human EGFR Mutations Quantitative Detection Kit (Real-time Fluorescent PCR Method)
Human EGFR(Epidermal Growth Factor Receptor) Mutations Quantitative Detection Kit (Real-time Fluorescent PCR Method)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
In this clinical trial, investigators select FFPE and plasma samples of non-small cell lung cancer which are used for quantitative detection of four kinds of EGFR(Epidermal Growth Factor Receptor) mutations. By the following two aspects, investigators evaluate the clinical performance of the EGFR quantitative kits. 1. methodology validation: To certify the equivalence between the EGFR quantitative kit and the common used detection methods. 2. analysis of the relationship between the type and proportion of EGFR sensitive mutation and EGFR-TKI benefit.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| EGFR-TKI Resistant Mutation | — | UNRESOLVED | — |
| EGFR-TKI Sensitizing Mutation | — | UNRESOLVED | — |
| Non Small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Plasma and tissue matching
- label
- predicting clinical efficacy
Primary outcomes (1)
- measure
- EGFR mutation detection of FFPE and plasma samples by Human EGFR Mutations Quantitative Detection Kit
- timeFrame
- 6 months
- description
- Each subject will be collected 3-10 FFPE samples and 3 ml plasma samples.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Plasma and tissue matching group: Inclusion Criteria: * 18\~80 years old * Diagnosis of NSCLC (stage III or IV) which is confirmed by histology or cytology methods. * Did not receive any anti-tumor treatment. * Sufficient samples for analysis Exclusion Criteria: * Female patients of childbearing potential who are nursing or are pregnant. * Samples are collected after patients receiving anti-tumor treatment. * The plasma sample hemolysis. * Tumor cells are not found in FFPE samples. * Incomplete information of subjects predicting clinical efficacy group: Inclusion Criteria: * 18\~80 years old * Diagnosis of NSCLC (stage III or IV) which is confirmed by histology or cytology methods. * At least one measurable focus * With EGFR-TKI treatment * Complete follow-up information after EGFR-TKI treatment * Sufficient samples for analysis Exclusion Criteria: * FFPE samples are collected after EGFR-TKI treatment. * Female patients of childbearing potential who are nursing or are pregnant. * Tumor cells are not found in FFPE samples. * Incomplete information of subjects
References
Publications (0)
Data not yet available