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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02381808

Enrollment

150

Registered

2015-03-06

Start date

2014-12-31

Completion date

2018-12-31

Last updated

2017-06-07

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

Conditions

Carcinoma, Non-Small-Cell Lung

Brief summary

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.

Detailed 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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Potential predictive biomarker to resistant to afatinib	baseline	Mutations of whole exon of 295 gene are analysed by deep sequencing in Chinese patients with NSCLC and their relationships with the patients' clinical features , 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

Countries

China

Outcome results