Squamous cell carcinoma of the lung
Conditions
Interventions
None listed
Sponsors
University of Miyazaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with lung squamous cell carcinoma 1.Patients aged equal to or greater than 20 years-old. 2.Patients diagnosed lung squamous cell carcinoma by surgical pathology(WHO Classification of Tumors of The Lung, Pleura, Thymus and Heart 4th edition). 3.Patients diagnosed pathological stage I lung squamous cell carcinoma(UICC-TNM Classification 8th edition). 4.Patients who had a detailed briefing of the trial prior to the enrollment and voluntarily signed a consent form. Healthy controls 1.Those who are equal to or greater than 20 years-old at the time of obtaining informed consent. 2.Those who have no abnormal findings in chest X-ray, blood glucose levels, serum lipids, serum liver function, serum renal function, and urinalysis within one year of obtaining informed consent. 3.Those who do not receive any regular prescriptions. 4.Those who are never smokers. 5.Those who had a detailed briefing of the trial prior to the enrollment and voluntarily signed a consent form.
Exclusion criteria
Exclusion criteria: Patients with lung squamous cell carcinoma 1.Patients who have proteinuria, positive urine sugar or urine occult blood in urinalysis. 2.Patients who have renal dysfunction (Serum levels of creatinine > 2.0 mg/dl). 3.Patients who do not undergo a curative surgery. 4.Patients who have current malignant neoplasm other than lung squamous cell carcinoma, or past history of malignant neoplasm within 5 years. 5.Patients who have alcohol or drug dependence or who are suspected to have alcohol or drug dependence. 6.Patients who is pregnant or who is suspected to be pregnant. 7.Patients who was enrolled another clinical trial and was prescribed a study drug within one month. 8.Patients who was not collected samples before curative surgery. 9.Patients whose attending physicians consider to be inappropriate for this study. Healthy controls 1.Those who have proteinuria, positive urine sugar or urine occult blood in urinalysis. 2.Those who have past history of malignant neoplasm within 5 years. 3.Those who have alcohol or drug dependence or who are suspected to have alcohol or drug dependence. 4.Those who are pregnant or who are suspected to be pregnant. 5.Those who were enrolled another clinical trial and were prescribed a study drug within one month. 6.Those who are current smokers or ex-smokers. 7.Those whose attending physicians consider to be inappropriate for this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Detection of candidates for a diagnostic urinary biomarker, whose sensitivity is higher than that of any other existing biomarker, of lung squamous cell carcinoma | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Sensitivity, specificity, positive likelihood ratio and negative likelihood ratio of the detected biomarkers. 2.Confirmation of the protein fragments, pre-fragmented proteins and cleaving enzymes in tissue and blood samples. 3.Relationship between the detected biomarkers and prognosis. 4.Relationship between the detected biomarkers and presence of metastasis. | — |
Countries
Japan
Contacts
Public ContactHironobu Tsubouchi
University of Miyazaki Neurology, Respirology, Endocrinology and Metabolism, Internal Medicine, Faculty of Medicine
Outcome results
None listed