Unique ID issued by UMIN | UMIN000030842 |
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Receipt number | R000034468 |
Scientific Title | Exploratory study of urinary shedding products as a novel biomarker for early stage lung squamous cell carcinoma |
Date of disclosure of the study information | 2018/01/18 |
Last modified on | 2023/05/18 13:47:35 |
Exploratory study of urinary shedding products as a novel biomarker for early stage lung squamous cell carcinoma
A urinary biomarker for early stage lung squamous cell carcinoma
Exploratory study of urinary shedding products as a novel biomarker for early stage lung squamous cell carcinoma
A urinary biomarker for early stage lung squamous cell carcinoma
Japan |
Squamous cell carcinoma of the lung
Pneumology |
Malignancy
NO
Urinary protein fragments of patients with lung squamous cell carcinoma are analyzed by mass spectrometry. The results of the exhaustive analysis are compared to those of healthy volunteers. The objective of this study is to identify protein fragments in urine, which are useful for detecting early stage lung squamous cell carcinoma.
Others
Exploration of a novel biomarker for lung squamous cell carcinoma
Detection of candidates for a diagnostic urinary biomarker, whose sensitivity is higher than that of any other existing biomarker, of lung squamous cell carcinoma
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.
Observational
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
80
1st name | Masamitsu |
Middle name | |
Last name | Nakazato |
University of Miyazaki
Neurology, Respirology, Endocrinology and Metabolism, Internal Medicine, Faculty of Medicine
8891692
5200 Kihara, Kiyotake, Miyazaki, Japan
0985-85-2965
nakazato@med.miyazaki-u.ac.jp
1st name | Hironobu |
Middle name | |
Last name | Tsubouchi |
University of Miyazaki
Neurology, Respirology, Endocrinology and Metabolism, Internal Medicine, Faculty of Medicine
889-1692
5200 Kihara, Kiyotake, Miyazaki, Japan
0985-85-2965
hironobu_tsubouchi@med.miyazaki-u.ac.jp
University of Miyazaki
Japan Agency for Medical Research and Development
Japanese Governmental office
University of Miyazaki Hospital, Clinical Research Support Center
5200 Kihara, Kiyotake, Miyazaki 889-1692, JAPAN
+81-985-85-2965
rinken@med.miyazaki-u.ac.jp
NO
2018 | Year | 01 | Month | 18 | Day |
Unpublished
Completed
2017 | Year | 12 | Month | 18 | Day |
2017 | Year | 12 | Month | 17 | Day |
2018 | Year | 01 | Month | 22 | Day |
2022 | Year | 03 | Month | 31 | Day |
2023 | Year | 05 | Month | 17 | Day |
No other related information
2018 | Year | 01 | Month | 16 | Day |
2023 | Year | 05 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034468
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