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The clinical trial on EGFR T790M mutation detection kit (digital PCR method)

The clinical trial on EGFR T790M mutation detection kit (digital PCR method)

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100043147
Enrollment
Unknown
Registered
2021-02-06
Start date
2018-04-01
Completion date
Unknown
Last updated
2021-05-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Non-small-cell Lung Cancer

Interventions

Gold Standard:The EGFR T790M mutation detected by the human EGFR gene mutation detection kit (fluorescent PCR method) produced by Xiamen Aide Biomedical Technology Co., Ltd.
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Sponsors

Cancer Hospital, Chinese Academy of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Clinically confirmed advanced non-small cell lung cancer; 2) Specific samples: small cell lung cancer and benign lung tumors; 3) Available peripheral blood plasma sample of non-small cell lung cancer patients ; 4) Available homologous tissue samples are the remaining paraffin-embedded tissue samples collected during the same period (within four weeks before and after the blood sampling) of the patient's plasma samples; 5) Subjects voluntarily participate in this study and sign an informed consent form. Note: The selected samples must meet the above 1) or 2) and meet the standards of 3) and 5); 4) is collected according to the actual situation.

Exclusion criteria

Exclusion criteria: 1) The time of sample collection or case information is not clear; 2) Those with insufficient sample size for testing; 3) Those who meet the selection criteria, but the researcher thinks they are not suitable for inclusion.

Design outcomes

Primary

MeasureTime frame
Positive coincidence rate;Negative coincidence rate;The total coincidence rate;Kappa value;

Countries

China

Contacts

Public ContactJie Wang

Department of Medical Oncology, Cancer Hospital Chinese Academy of Medical Sciences

zlhuxi@163.com+86 13910704669

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 14, 2026