NCT01994057 A Retrospective Study of EGFR-TKIs,Gefitinib, Erlotinib and Osimertinib in NSCLC Patients Treatment
| NCT ID | NCT01994057 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Sun Yat-sen University |
| Condition | Non-small Cell Lung Cancer (NSCLC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2012-09 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2012-09 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Min Huang, Professor
STUDY CHAIR
school of pharmaceutical sciences , SunYat-senU
Frequently Asked Questions
Who can join the NCT01994057 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Non-small Cell Lung Cancer (NSCLC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT01994057 currently recruiting?
Yes, NCT01994057 is actively recruiting participants. Contact the research team at guanshx6@mail.sysu.edu.cn for enrollment information.
Where is the NCT01994057 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT01994057 clinical trial?
NCT01994057 is sponsored by Sun Yat-sen University. The principal investigator is Min Huang, Professor at school of pharmaceutical sciences , SunYat-senU. The trial plans to enroll 1,000 participants.
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