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出境医 / 临床实验 / The Role of Protein Tyrosine Kinase 7 (PTK7) in Non-small Cell Lung Cancer

The Role of Protein Tyrosine Kinase 7 (PTK7) in Non-small Cell Lung Cancer

Study Description
Brief Summary:
To understand the mechanism and cellular functions of PTK7-associated signaling pathways in promoting lung cancer progression and conferring treatment to epidermal growth factor receptor tysosine kinase inhibitors (EGFR TKIs).

Condition or disease
Tumor Progression

Detailed Description:
  • 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 Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 167 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: The Role of Protein Tyrosine Kinase 7 (PTK7) in Non-small Cell Lung Cancer: Functional Analysis and Molecular Mechanism Study
Actual Study Start Date : April 19, 2019
Actual Primary Completion Date : March 24, 2020
Actual Study Completion Date : March 24, 2020
Arms and Interventions
Outcome Measures
Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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
Biopsy tissue, DNA, RNA

Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   20 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
only citizens of Taiwan will be enrolled.
Criteria

Inclusion Criteria:

  • Residual specimens under the project (201103013RC: RNA based gene testing using diagnostic minute samples for personalized therapy of lung cancer) will be used in the study.
  • Patients have signed the informed consent (201103013RC) before 2019/01/31 and authorized the Institutional Review Board of Nation Taiwan University Hospital to review the new study for approving the usage of residual specimens.
  • The residual samples from various sources, including surgical tissues, computed tomography (CT)-guided needle aspiration and/or biopsy, echo-guided needle aspiration and /or biopsy, bronchoscopic biopsy or brushing, bronchoalveolar lavage (BAL), endobronchial ultrasound guided needle aspiration, and lymph node aspiration, and pleural effusion specimens. The samples will be collected at the time of diagnostic procedure performed. All patients should sign an informed consent for purpose of using samples for molecular genetic testing.
  • 600 residual specimens will be used for the study.

Exclusion Criteria:

  • Patients didn't sign the informed consent (201103013RC).
  • The residual specimens are not qualified.
  • Patients didn't take epidermal growth factor receptor inhibitors.
Contacts and Locations

Locations
Layout table for location information
Taiwan
Jin-Yuan Shih
Taipei, Taiwan
Sponsors and Collaborators
National Taiwan University Hospital
Tracking Information
First Submitted Date May 16, 2019
First Posted Date July 12, 2019
Last Update Posted Date March 25, 2020
Actual Study Start Date April 19, 2019
Actual Primary Completion Date March 24, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 11, 2019) 		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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 11, 2019) 		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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title The Role of Protein Tyrosine Kinase 7 (PTK7) in Non-small Cell Lung Cancer
Official Title The Role of Protein Tyrosine Kinase 7 (PTK7) in Non-small Cell Lung Cancer: Functional Analysis and Molecular Mechanism Study
Brief Summary To understand the mechanism and cellular functions of PTK7-associated signaling pathways in promoting lung cancer progression and conferring treatment to epidermal growth factor receptor tysosine kinase inhibitors (EGFR TKIs).
Detailed Description
  • 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
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Biopsy tissue, DNA, RNA
Sampling Method Probability Sample
Study Population only citizens of Taiwan will be enrolled.
Condition Tumor Progression
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 24, 2020) 		167
Original Estimated Enrollment
 (submitted: July 11, 2019) 		600
Actual Study Completion Date March 24, 2020
Actual Primary Completion Date March 24, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Residual specimens under the project (201103013RC: RNA based gene testing using diagnostic minute samples for personalized therapy of lung cancer) will be used in the study.
  • Patients have signed the informed consent (201103013RC) before 2019/01/31 and authorized the Institutional Review Board of Nation Taiwan University Hospital to review the new study for approving the usage of residual specimens.
  • The residual samples from various sources, including surgical tissues, computed tomography (CT)-guided needle aspiration and/or biopsy, echo-guided needle aspiration and /or biopsy, bronchoscopic biopsy or brushing, bronchoalveolar lavage (BAL), endobronchial ultrasound guided needle aspiration, and lymph node aspiration, and pleural effusion specimens. The samples will be collected at the time of diagnostic procedure performed. All patients should sign an informed consent for purpose of using samples for molecular genetic testing.
  • 600 residual specimens will be used for the study.

Exclusion Criteria:

  • Patients didn't sign the informed consent (201103013RC).
  • The residual specimens are not qualified.
  • Patients didn't take epidermal growth factor receptor inhibitors.
Sex/Gender
Sexes Eligible for Study: All
Ages 20 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number NCT04018183
Other Study ID Numbers 201902071RINC
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor National Taiwan University Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account National Taiwan University Hospital
Verification Date May 2019

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