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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000030841 |
Receipt No. | R000034131 |
Scientific Title | Exploratory study of urinary shedding products as a novel biomarker for lung small cell carcinoma |
Date of disclosure of the study information | 2018/01/18 |
Last modified on | 2018/07/24 |
Basic information | ||
Public title | Exploratory study of urinary shedding products as a novel biomarker for lung small cell carcinoma | |
Acronym | A urinary biomarker for lung small cell carcinoma | |
Scientific Title | Exploratory study of urinary shedding products as a novel biomarker for lung small cell carcinoma | |
Scientific Title:Acronym | A urinary biomarker for lung small cell carcinoma | |
Region |
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Condition | ||
Condition | Small cell lung carcinoma | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | Urinary protein fragments of patients with small cell lung 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 small cell lung carcinoma. |
Basic objectives2 | Others |
Basic objectives -Others | Exploration of a novel biomarker for small cell lung carcinoma |
Trial characteristics_1 | Exploratory |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Detection of candidates for a diagnostic urinary biomarker of small cell lung carcinoma |
Key secondary outcomes | 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. |
Base | |
Study type | Observational |
Study design | |
Basic design | |
Randomization | |
Randomization unit | |
Blinding | |
Control | |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | |
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Purpose of intervention | |
Type of intervention | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients with small cell lung carcinoma
1.Patients aged equal to or greater than 20 years-old. 2.Patients diagnosed primary lung cancer. 3.Patients diagnosed small cell lung carcinoma by cytology or histology(2015 WHO Classification of Lung Tumors). 4.Previously untreated patients with small cell lung carcinoma. 5.Patients who had a detailed briefing of the trial prior to the enrollment and voluntarily signed a consent form. Healthy controls 1.Those who age 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 prescription. 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. |
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Key exclusion criteria | 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. |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | University of Miyazaki | ||||||
Division name | Neurology, Respirology, Endocrinology and Metabolism, Internal Medicine, Faculty of Medicine | ||||||
Zip code | |||||||
Address | 5200 Kihara, Kiyotake, Miyazaki, Japan | ||||||
TEL | 0985-85-2965 | ||||||
nakazato@med.miyazaki-u.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | University of Miyazaki | ||||||
Division name | Neurology, Respirology, Endocrinology and Metabolism, Internal Medicine, Faculty of Medicine | ||||||
Zip code | |||||||
Address | 5200 Kihara, Kiyotake, Miyazaki, Japan | ||||||
TEL | 0985-85-2965 | ||||||
Homepage URL | |||||||
nobuhiro@med.miyazaki-u.ac.jp |
Sponsor | |
Institute | University of Miyazaki |
Institute | |
Department |
Funding Source | |
Organization | Japan Agency for Medical Research and Development |
Organization | |
Division | |
Category of Funding Organization | Japanese Governmental office |
Nationality of Funding Organization | Japan |
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Secondary IDs | |
Secondary IDs | NO |
Study ID_1 | |
Org. issuing International ID_1 | |
Study ID_2 | |
Org. issuing International ID_2 | |
IND to MHLW |
Institutions | |
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Date of disclosure of the study information |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Progress | |||||||
Recruitment status | Open public recruiting | ||||||
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Other | |
Other related information | No other related information |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034131 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
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Research case data | |
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