UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027596 |
|---|---|
| Receipt number | 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 | 2023/01/05 19:52:58 |
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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
Name of lead principal investigator
| 1st name | Shomei |
| Middle name | |
| Last name | Ryozawa |
Organization
Saitama Medical University International Medical Center
Division name
Department of Gastroenterology
Zip code
350-1298
Address
1397-4 Yamane, Hidaka, Saitama 350-1298, Japan
TEL
042-984-4111
ryozawa@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Kobayashi |
Organization
Saitama Medical University International Medical Center
Division name
Department of Gastroenterology
Zip code
350-1298
Address
1397-4 Yamane, Hidaka, Saitama 350-1298, Japan
TEL
042-984-4111
Homepage URL
mkobayashi.gast@tmd.ac.jp
Sponsor or person
Institute
Saitama Medical University International Medical Center
Institute
Department
Personal name
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
Saitama Medical University International Medical Center, Center for the Promotion of Appropriate Clinical Research
Address
1397-4 Yamane, Hidaka, Saitama 350-1298, Japan
Tel
042-984-4523
chikens@saitama-med.ac.jp
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
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
441
Results
There were 95 noncancer cases and 104 pancreatic cancer cases. The sensitivity and specificity of N-NOSE for pancreatic cancer were
84.6% (88/104) and 60%(57/95), respectively. N-NOSE was able to detect stages 0 to I pancreatic cancer and had a higher correlation with early-stage pancreatic cancer than advanced stage.
Results date posted
| 2021 | Year | 06 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 05 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2017 | Year | 05 | Month | 24 | Day |
Date of IRB
| 2017 | Year | 05 | Month | 24 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2023 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 03 | Month | 31 | Day |
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
| 2023 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031395
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
