Tumor ProgressionNCT04018183
The Role of Protein Tyrosine Kinase 7 (PTK7) in Non-small Cell Lung Cancer
An observational study of Tumor Progression, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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). Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Tumor Progression
- How many people
- 167 participants
- Where
- 1 siteTaiwan
- Study dates
- 19 Apr 2019to 24 Mar 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: only citizens of Taiwan will be enrolled.
Who may be able to join
- 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.
Who cannot join
- Patients didn't sign the informed consent (201103013RC).
- The residual specimens are not qualified.
- Patients didn't take epidermal growth factor receptor inhibitors.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Protein Tyrosine Kinase 7 (PTK7) in Non-small Cell Lung Cancer: Functional Analysis and Molecular Mechanism Study
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).
Read the 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.).
- Conditions
- Tumor Progression
- Keywords
- non-small cell lung cancer, epidermal growth factor receptor tyrosine inhibitor
- Medical subject headings
- Disease Progression, Carcinoma, Non-Small-Cell Lung
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor size measurement for evaluating tumor 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.
Measured: "up to 5 years," "from date of treatment (EGFR TKIs) until the date of first documented progression
Secondary outcomes (1)
Lymph node lesion measurement for evaluating tumor 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.
Measured: "up to 5 years," "from date of treatment (EGFR TKIs) until the date of first documented metastasis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start19 Apr 2019
- Primary completion24 Mar 2020
- Study completion24 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tumor ProgressionStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 167 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018183
- Sponsor's protocol ID
- 201902071RINC
- Status last verified
- May 2019
- First submitted
- 16 May 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Protein Tyrosine Kinase 7 (PTK7) in Non-small Cell Lung Cancer: Functional Analysis and Molecular Mechanism Study
- ClinicalTrials.gov ID
- NCT04018183
- Acronym / sponsor ID
- 201902071RINC
- Conditions
- Tumor Progression
- Keywords
- non-small cell lung cancer, epidermal growth factor receptor tyrosine inhibitor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 167 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 24 Mar 2020 (actual)
- Study completion
- 24 Mar 2020 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- only citizens of Taiwan will be enrolled.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients didn't sign the informed consent (201103013RC).
- The residual specimens are not qualified.
- Patients didn't take epidermal growth factor receptor inhibitors.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tumor Progression, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.