An observational study in Chinese and Non-Small Cell Lung Cancer, sponsored by Shanghai Pulmonary Hospital, Shanghai, China. Status unknown at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-12-27.
Sponsored by Shanghai Pulmonary Hospital, Shanghai, China · Observational
Title: Multicenter observational study for clinicopathological characteristics and clinical efficacy of Chinese Non-Small Cell Lung Cancer (NSCLC) patients With Rare Driver Gene Mutation.
Purpose: To observe the status of rare driver gene mutations in NSCLC patients and identify the subtypes of the mutations.
By comparing and analyzing the relationship between different subtypes, clinicopathological features and clinical efficacy, to find out the effects on anti-tumor therapy and disease survival.
And ultimately to promote the precise application of clinical specifications for new anti-tumor drugs.
Study type: Observational
Inclusion criteria:
Exclusion criteria:
Estimated enrollment: 50000 participants.
Outcome measures:
Primary outcome measures：
Secondary outcome measures:
Method of Research:
Pre- entry/screening period (V0)
Baseline period (V1)
a. Do further classification of rare driver gene mutation positive samples by Sanger sequencing, and record the test results;
Follow-up period (V2)
Materials and Methods:
Materials:
The specimen material must be human genomic DNA and total RNA extracted from tumor tissue samples. Before the extraction of DNA and RNA, it is very important to make sure that there is at least 20% tumor cells in the tumor tissue samples.
Methods:
Epidermal Growth Factor Receptor 20 exon insertion (EGFR exon 20-ins) mutation/Activin Receptor-like Kinase (ALK) fusion/ROS proto-oncogene 1 receptor tyrosine kinase (ROS1) fusion/Kirsten Rat Sarcoma Viral Oncogene Homolog (KRAS) mutation/Neuroblastoma RAS viral oncogene homolog (NRAS) mutation/B-Raf proto-oncogene, serine/threonine kinase (BRAF) mutation/Phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA) mutation/RET proto-oncogene (RET) fusion/Mesenchymal-Epithelial Transition factor (MET) 14 exon skipping/Erb-b2 Receptor Tyrosine Kinase 2 (ERBB2) mutation/ Neurotrophic-Tropomyosin Receptor Kinase (NTRK) fusion mutation were detected by Fluorogenic Quantitative Polymerase Chain Reaction in Chinese NSCLC.
DNA/RNA Extraction:
The total RNA concentration for gene fusion detection is 10\~100 ng/µL in Formalin-Fixed Paraffin-Embedded (FFPE) tissue or 2\~30 ng/µL in Fresh tissue.
The amount of extracted DNA for gene mutation detection is 1.5\~3 ng/µL in FFPE tissue or 0.5\~1 ng/µL in Fresh tissue.
Detection of the Target Alterations in RNA and DNA:
ALK, ROS1, RET, NTRK Gene fusion and MET 14 exon skipping mutation were detected in RNA.
EGFR 20 exon-ins, KRAS, NRAS, BRAF, PIK3CA and ERBB2 mutation were detected in DNA.
7,243 studies on the registry are indexed under Lung Neoplasms; 1,557 are open to participants now.
This study's planned enrollment of 50,000 is above the median of 189 across 1,514 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Shanghai Pulmonary Hospital, Shanghai, China is the lead sponsor of 149 studies on the registry; 91 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Histologically or cytologically proven diagnosis of NSCLC
Exclusion Criteria:
Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction (PCR) panel kit in the hospital requires the use of tissue samples and the results show a rare driver gene mutation positive.
Other: nonIntervention
Screen the enrolled patients according to the admission criteria. The detection of lung cancer Polymerase Chain Reaction(PCR)panel kit in the hospital requires the use of tissue samples and the results show a rare driver gene mutation negative.
Other: nonIntervention
nonIntervention
Driver gene mutation frequency of Chinese NSCLC patients
Analyze the rare driver gene mutation frequency in NSCLC patients in the real world.
Time frame: 2022
Clinicopathological characteristics of Chinese NSCLC patients With Rare Driver Gene Mutation
Observe the clinicopathological features in NSCLC patients with rare gene mutation in the real world.
Time frame: 2022
Relationship of Clinicopathological characteristics and Rare Driver Gene Mutation of Chinese NSCLC patients
Analyze the relationship between rare driver gene subtypes and clinicopathological features in NSCLC patients.
Time frame: 2022
Objective response rate of Chinese NSCLC patients With Rare Driver Gene Mutation
The relationship between rare driver gene mutation subtypes and objective response rate in NSCLC patients. Objective response rate(ORR): ORR = (number of subjects with complete response (CR) + partial response (PR)) / total number of subjects × 100%, 95% confidence interval(CI) was calculated using binomial distribution, and the calculation of objective response rate was based on the quadratic confirmed optimal efficacy evaluation.
Time frame: 2024
Progression-free survival of Chinese NSCLC patients With Rare Driver Gene Mutation
The relationship between rare driver gene mutation subtypes and progression-free survival in NSCLC patients. Progression-free survival (PFS): PFS refers to the time (month) between the date of randomization to the first demonstration of disease progression or death (whichever occurs first).
Time frame: 2024
Overall survival of Chinese NSCLC patients With Rare Driver Gene Mutation
The relationship between rare driver gene mutation subtypes and overall survival in NSCLC patients. Overall survival (OS): OS refers to the time of first use of the drug to the time of death. At the end of the study, if the subject is still alive, refer the known "date of last survival of the subject" as the date of censoring.
Time frame: 2024
Plan to share: No
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Shanghai Pulmonary Hospital, Shanghai, China