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A Retrospective Pharmacogenomics Research of EGFR-TKIs,Gefitinib and Erlotinib, in NSCLC Patients Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01994057
Recruitment Status : Recruiting
First Posted : November 25, 2013
Last Update Posted : November 10, 2020
Information provided by (Responsible Party):
Guan shaoxing, PHD, Sun Yat-sen University

Brief Summary:
For patients of advanced NSCLC (non small cell lung cancer) , Individualized cancer therapy has been widely accepted since the success of crizotinib administration based on EML4-ALK fusion gene detection and gefitinib and erlotinib administration based on EGFR-TKIs sensitive mutations.From clinical points of view ,individual differences often occur between different patients, leading diverse effect in ADR and drug effect.Meanwhile ,the drug effect and adverse drug reaction was significantly influenced by the pharmacokinetic factors and pharmacodynamic factors.In this research ,we try to establish a more sensitive method to detect sensitive mutations in plasma and discover the correlation between somatic and germline mutations , trough concentration and EGFR-TKI drug effect, the association between ADME-associated SNP ,trough concentration and EGFR-TKI adverse effect .Furthermore, in vivo and in vitro research is also crucial for rational explanation for these clinical phenomenon.

Condition or disease
Non-small Cell Lung Cancer (NSCLC) EGFR-TKI Resistant Mutation EGFR-TKI Sensitizing Mutation Germline Mutations Somatic Mutation

Detailed Description:
The ADME-associated SNPs included are CYP3A4,CYP3A4,CYP1A1,CYP2D6, ABCB1,ABCG2 and so on .The somatic mutations included are EGFR ,K-RAS ,ALK and so on

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Retrospective Study Based on Somatic Mutations, Genetic Polymorphisms and Metabolomics Related to Individual Variations of Drug Effect and Adverse Drug Reaction of EGFR-TKIs,Gefitinib and Erlotinib in Non-small Cell Lung Cancer Treatment.
Study Start Date : September 2013
Estimated Primary Completion Date : October 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

sensitive group; resistant group

sensitive patients were defined as patients reached CR or PR after first month administration,SD after first three months administration.

resistant patients were defined as patients reached PD after first month administration and first three months administration

Primary Outcome Measures :
  1. Progression free survival [ Time Frame: The length of time from either the date of diagnosis to that patients diagnosed with the disease are still alive ]
    Excluding clinical deterioration without evidence of objective progression according to the Response Evaluation Criteria In Solid Tumors (RECIST), or death from any cause.

Secondary Outcome Measures :
  1. Number of patients with objective response and adverse events [ Time Frame: one month, three month ]

    Objective responses (complete response plus partial response) and disease control (objective response plus stable disease

    ≥6 weeks) were established according to RECIST.And adverse events was established according to NCI-CTC .

Other Outcome Measures:
  1. Number of patients with ADR [ Time Frame: one month, three month ]
    Such as rash

Biospecimen Retention:   Samples With DNA
  1. FFPE samples of tissue needle biopsy were used for EGFR mutation detection.
  2. EDTA-whole blood was centrifuged at 4000rpm*10min,plasma was separated within four hours for somatic mutation detection.The remaining samples were used for germline mutation detection. All the blood samples were frozen in -80℃ until analysis.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
locally advanced or metastatic NSCLC (non-small cell lung cancer) patients; administrated with gefitinib,erlotinib .

Inclusion Criteria:

The main patient entry criteria included: age≥ 18 years ; histologically and cytologically proved NSCLC; Eastern cooperative oncology group performance status (ECOG PS)≤2; adequate hematological , renal, and hepatic functions. Exclusion Criteria:

uncontrolled systemic disease ,any evidence of clinically active interstitial lung diseases, and other chemotherapy at the time of inclusion. The protocol was approved by the Ethical Committee of Cancer Center of Sun Yat-Sen University (CCSU), and written informed consent was obtained form each patient.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01994057

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Contact: Shaoxing Guan, PHD +86 13129351756 ext +8613129351756
Contact: Min Huang, Professor +86 020 87331409-101

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China, Guangdong
Cancer Center, Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510060
Contact: Shuang Xin, PHD    +86 13580479553   
Contact: Shaoxing Guan, PHD    +86 13129351756 ext 13129351756   
Principal Investigator: Min Huang, Professor         
Sponsors and Collaborators
Sun Yat-sen University
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Study Chair: Min Huang, Professor school of pharmaceutical sciences , SunYat-senU
Additional Information:

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Responsible Party: Guan shaoxing, PHD, PHD, Sun Yat-sen University Identifier: NCT01994057    
Other Study ID Numbers: 2012ZX09506001-004 (2)
(2) ( Other Identifier: China: National Natural Science Foundation )
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: November 10, 2020
Last Verified: November 2020
Keywords provided by Guan shaoxing, PHD, Sun Yat-sen University:
Non-small cell lung cancer (NSCLC);
Precision medicine
somatic mutations ,germline mutations;
Additional relevant MeSH terms:
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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms