Exploratory study of urinary shedding products as a novel biomarker for early stage lung squamous cell carcinoma

Not Applicable

• Conditions: Squamous cell carcinoma of the lung

• Registration Number: JPRN-UMIN000030842
• Lead Sponsor: niversity of Miyazaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-01-18
• Study Completion: 2022-03-31
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

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.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.