The Role of Protein Tyrosine Kinase 7 (PTK7) in Non-small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT04018183|
Recruitment Status : Not yet recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
|Condition or disease|
- RNA extraction: We will extract total RNA from cell lysates by using Tri-reagent (Molecular Research Center, Inc., Cincinnati, Ohio) and an RNA Mini Kit (Qiagen, Hilden, Germany) according to the manufacturer's instruction. RNA obtained from the Mini Kit column will be eluted. The quantity and quality of the purified RNA will be evaluated using a NanoDrop ND-1000 spectrophotometer will be stored at -80 °C for further mutational analyses.
- Data acquisition: We will record and follow patients' clinical information, including ethnicity, age, gender, smoking status, histological types, lung cancer stage (the TNM status), metastatic sites, ECOG score, CT/CXR imaging, chemotherapy or radiation treatment at the time of diagnosis of lung cancer and through the entire clinical courses. Specific marker such as TTF1, is used to ensure the diagnosis of primary lung tumor. Clinicopathologic stage assigns according to the seventh tumor-node-metastasis classification. We assess the treatment responses according to the Response Evaluation Criteria in Solid Tumors (RECIST) using the unidimension method, and record the best response achieved per treatment. Treatment response, progression-free survival, and overall survival are recorded prospectively for further analysis.
- Statistical analysis: All categorical variables will be analyzed with Pearson's χ² test, except where a small size required the use of Fisher's exact test. The progression-free survival curve and overall survival will be plotted by the Kaplan-Meier method and compared by the log-rank test. Multivariate analysis for overall survival will be performed using the Cox's proportional hazards model. Two-sided p-values of less than 0.05 is considered significant. All analyses will be performed using SPSS software (version 16.0 for Windows; SPSS Inc.).
|Study Type :||Observational|
|Estimated Enrollment :||600 participants|
|Official Title:||The Role of Protein Tyrosine Kinase 7 (PTK7) in Non-small Cell Lung Cancer: Functional Analysis and Molecular Mechanism Study|
|Estimated Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||June 30, 2022|
|Estimated Study Completion Date :||June 30, 2022|
- Tumor size measurement for evaluating tumor progression [ Time Frame: "up to 5 years," "from date of treatment (EGFR TKIs) until the date of first documented progression ]
The change of tumor size is indicative of progression disease (PD) after EGFR TKI treatment.
Tumor size is recorded using CT scan before the first day of of treatment and routine CT scan image is captured at each cycle of treatment to evaluate the growth of tumor.
According to RECIST (The Response Evaluation Criteria in Solid Tumors), tumor progression will be assigned based on (1) a sum measurement of original target lesions that has increased more than 20%, (2) the reappearance of the original target lesions, (3) appearance of new lesions, and (4) a new lymph node metastatic lesion which is more than 10mm in diameter. Statistically, patients will be divided into two groups according to expression level of PTK7 mRNA, which is detected before the first dayof treatment. The clinicopathologic characteristics (sex, age, smoking history, EGFR mutation) will be enrolled in multivariate analysis.
- Lymph node lesion measurement for evaluating tumor metastasis [ Time Frame: "up to 5 years," "from date of treatment (EGFR TKIs) until the date of first documented metastasis ]Lymph node metastatic lesion is recorded using CT scan before the first day of treatment and routine CT scan image is captured at each cycle of EGFR TKI treatment. A new lymph node metastatic lesion which is more than 10mm in diameter is considered as tumor metastasis.Statistically, patients will be divided into two groups according to expression level of PTK7 mRNA, which is detected before the first day of of treatment. The clinicopathologic characteristics (sex, age, smoking history, EGFR mutation) will be enrolled in multivariate analysis.
Biospecimen Retention: Samples With DNA
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): NCT04018183
|Contact: JIN-YUAN SHIH, PhD,MD||+886-2-23123456 ext firstname.lastname@example.org|