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

NCT04018183 | Completed

• 1 other identifier: 201902071RINC
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 1

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).

Conditions

Tumor Progression

Keywords

non-small cell lung cancer; epidermal growth factor receptor tyrosine inhibitor

Outcome Measures

Primary Outcomes (1)

• 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.

  "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

  "up to 5 years," "from date of treatment (EGFR TKIs) until the date of first documented metastasis

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

only citizens of Taiwan will be enrolled.

You may qualify if:

• 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.
• residual specimens will be used for the study.

You may not qualify if:

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

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

Jin-Yuan Shih

Taipei, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biopsy tissue, DNA, RNA

MeSH Terms

Conditions

Disease Progression; Carcinoma, Non-Small-Cell Lung

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2019
• First Posted: July 12, 2019
• Study Start: April 19, 2019
• Primary Completion: March 24, 2020
• Study Completion: March 24, 2020
• Last Updated: March 25, 2020

Record last verified: 2019-05

Locations

TW (1)