Exploratory study of urinary shedding products as a novel biomarker for lung small cell carcinoma
- Conditions
- Small cell lung carcinoma
- Registration Number
- JPRN-UMIN000030841
- Lead Sponsor
- niversity of Miyazaki
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
Not provided
Patients with small cell lung carcinoma 1.Patients who has been already received any treatments for small cell lung carcinoma. 2.Patients who have proteinuria, positive urine sugar or urine occult blood in urinalysis. 3.Patients who have renal dysfunction (Serum levels of creatinine > 2.0 mg/dl). 4.Patients who have current malignant neoplasm other than small cell lung 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 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 of small cell lung 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.