A Retrospective Pharmacogenomics Research of EGFR-TKIs,Gefitinib and Erlotinib, in NSCLC Patients Treatment
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| ClinicalTrials.gov Identifier: NCT01994057 |
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Recruitment Status :
Recruiting
First Posted : November 25, 2013
Last Update Posted : November 10, 2020
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| Condition or disease |
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| Non-small Cell Lung Cancer (NSCLC) EGFR-TKI Resistant Mutation EGFR-TKI Sensitizing Mutation Germline Mutations Somatic Mutation |
| 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 |
| Group/Cohort |
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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 |
- 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.
- 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 .
- Number of patients with ADR [ Time Frame: one month, three month ]Such as rash
Biospecimen Retention: Samples With DNA
- FFPE samples of tissue needle biopsy were used for EGFR mutation detection.
- 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.
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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 |
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.
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 ClinicalTrials.gov identifier (NCT number): NCT01994057
| Contact: Shaoxing Guan, PHD | +86 13129351756 ext +8613129351756 | guanshx3@mail2.sysu.edu.cn | |
| Contact: Min Huang, Professor | +86 020 87331409-101 | huangmin@mail.sysu.edu.cn |
| China, Guangdong | |
| Cancer Center, Sun Yat-sen University | Recruiting |
| Guangzhou, Guangdong, China, 510060 | |
| Contact: Shuang Xin, PHD +86 13580479553 xshuang@mail2.sysu.edu.cn | |
| Contact: Shaoxing Guan, PHD +86 13129351756 ext 13129351756 guanshx3@mail2.sysu.edu.cn | |
| Principal Investigator: Min Huang, Professor | |
| Study Chair: | Min Huang, Professor | school of pharmaceutical sciences , SunYat-senU |
Publications:
| Responsible Party: | Guan shaoxing, PHD, PHD, Sun Yat-sen University |
| ClinicalTrials.gov 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 |
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Non-small cell lung cancer (NSCLC); EGFR-TKI; Pharmacogenetics; Precision medicine somatic mutations ,germline mutations; |
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Lung Neoplasms Carcinoma, Non-Small-Cell Lung Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site |
Neoplasms Lung Diseases Respiratory Tract Diseases Carcinoma, Bronchogenic Bronchial Neoplasms |