UMIN-CTR Clinical Trial

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	Japan

Condition
Condition	Small cell lung carcinoma
Classification by specialty	Pneumology
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
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
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.
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.
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Masamitsu Nakazato
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
Email	nakazato@med.miyazaki-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Nobuhiro Matsumoto
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
Email	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

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
Institutions

Other administrative information
Date of disclosure of the study information	2018 Year 01 Month 18 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Open public recruiting
Date of protocol fixation	2017 Year 12 Month 27 Day
Date of IRB
Anticipated trial start date	2018 Year 01 Month 22 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	No other related information

Management information
Registered date	2018 Year 01 Month 16 Day
Last modified on	2018 Year 07 Month 24 Day

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
Registered date	File name

Research case data
Registered date	File name

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