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

NCT ID: NCT02381808

Last Updated: 2017-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-12-31

Study Completion Date

2018-12-31

Brief Summary

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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

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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.

Conditions

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Carcinoma, Non-Small-Cell Lung

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Boehringer Ingelheim

INDUSTRY

Sponsor Role collaborator

Guangdong Association of Clinical Trials

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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China China

Role: STUDY_CHAIR

Guang general hospital,Guangzhou, Guangdong, China, 510080

Locations

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Guangdong General Hospital & Guangdong Academy of Medical Sciences

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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BI1200.250

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CTONG1502

Identifier Type: -

Identifier Source: org_study_id

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