Study on Potential Biomarkers Associated With Clinical Phenotype of EGFR-TKIs in No-small Cell Lung Cancer in China

Guangdong Association of Clinical Trials

Status: Unknown

Conditions: Carcinoma, Non-Small-Cell Lung

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02381808

CTONG1502

BI1200.250 (Other Grant/Funding Number)

Details and patient eligibility

About

To understand 295 gene mutation mutation status (include EGFR, HER2, KRAS, BRAF, PIK3CA,ect) by deep sequencing in Chinese patients with pulmonary adenocarcinoma and their relationships with the patients' clinical features (including sex, age, smoking history and adenocarcinoma subtype), specify the predictive significance of the genes mutations for new targeted therapies in NSCLC patients, and better understand the molecular mechanism drug resistance to EGFR-TKIs.

Full description

This study is prospective to identify biomarkers to resistant to afatinib，gefitinib and erlotinib in non-small cell lung cancer patients. Mutations of whole exon of 295 gene are analysed by deep sequencing in Chinese patients with non-small cell lung cancer and their relationships with the patients' clinical features (including sex, age, smoking history and adenocarcinoma subtype), specify the predictive significance of the genes mutations for new targeted therapies in NSCLC patients, and better understand the molecular mechanism drug resistance to EGFR-TKIs.

Enrollment: 150 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age>18 years,both male and female
• Histologically confirmed patients with pulmonary adenocarcinoma (Stage I-IV)
• ECOG 0-2
• Patients with enough paraffin tissue specimens or fresh tissue for detection
• Quality of the DNA extracted from the tissue samples ensures that the DNA can be used in DNA sequencing
• Subjects who provide detailed clinical and follow-up information

Exclusion criteria

• Patients with other tumors
• Patients suffering from other serious diseases like infectious diseases (viral hepatitis, HIV,etc)
• Pregnant women shall be excluded