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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000027596
Receipt No. R000031395
Scientific Title A validation study to evaluate a novel cancer screening using C. elegans
Date of disclosure of the study information 2017/06/01
Last modified on 2017/06/01

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Basic information
Public title A validation study to evaluate a novel cancer screening using C. elegans
Acronym A validation study to evaluate a novel cancer screening using C. elegans
Scientific Title A validation study to evaluate a novel cancer screening using C. elegans
Scientific Title:Acronym A validation study to evaluate a novel cancer screening using C. elegans
Region
Japan

Condition
Condition All malignancies
Classification by specialty
Gastroenterology Hepato-biliary-pancreatic medicine Pneumology
Hematology and clinical oncology Surgery in general Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Chest surgery Breast surgery
Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficiency of N-NOSE which is the new cancer screening using C.elegans.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To calculate the sensitivity and specificity of N-NOSE for various cancers and examine speriority with the existing tumor markers.
Key secondary outcomes

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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1. all patients who visit our hospital.
2. patients who consent to this study.
3. In the cancer patients, Informed consent is carried out and the fact of cancer is announced.
Key exclusion criteria 1. the one who can not obtain urine sample such as dyalysis patients
Target sample size 900

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Shomei Ryozawa M.D. Ph.D.
Organization Saitama Medical University International Medical Center
Division name Department of Gastroenterology
Zip code
Address 1397-4 Yamane, Hidaka, Saitama 350-1298, Japan
TEL 042-984-4111
Email ryozawa@saitama-med.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Masanori Kobayashi M.D. Ph.D.
Organization Saitama Medical University International Medical Center
Division name Department of Gastroenterology
Zip code
Address 1397-4 Yamane, Hidaka, Saitama 350-1298, Japan
TEL 042-984-4111
Homepage URL
Email mkobayashi.gast@tmd.ac.jp

Sponsor
Institute Saitama Medical University International Medical Center
Institute
Department

Funding Source
Organization self-sustaining
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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
2017 Year 06 Month 01 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 05 Month 24 Day
Date of IRB
Anticipated trial start date
2017 Year 06 Month 13 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is the analytic observational study. The patients who visit our hospital from 1st June 2017 to 31st march 2019 are include if they meet the selection criteria. The urine samples are obtained for N-NOSE from all of them. Moreover, age, sex, height, body weight, diagnosis, disease stage, the results of image examination, pathological diagnosis, treatment regimen, past medical histories, family histories, complications and the result of blood test are collected.

Management information
Registered date
2017 Year 06 Month 01 Day
Last modified on
2017 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031395

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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