UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011814 |
|---|---|
| Receipt number | R000013803 |
| Scientific Title | Development of non-invasive method for the detection of mutated circulating nuclear acid |
| Date of disclosure of the study information | 2013/09/19 |
| Last modified on | 2021/03/25 11:37:18 |
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Basic information
Public title
Development of non-invasive method for the detection of mutated circulating nuclear acid
Acronym
Development of non-invasive method for the detection of mutated circulating nuclear acid
Scientific Title
Development of non-invasive method for the detection of mutated circulating nuclear acid
Scientific Title:Acronym
Development of non-invasive method for the detection of mutated circulating nuclear acid
Region
| Japan |
Condition
Condition
Pancreatic cancer
Colon cancer
Hepatocellar carcinoma
Gastric cancer
Bile duct cancer
Inflammatory bowel disease
(Ulcerative colitis, Crohn)
Intraductal papillary mucinous neoplasm
Autoimmune disease
Hepatic/ digestive tract disorder
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The objectives of this study are: to measure the concentrations of circulating DNA in blood and body fluids before and after examination in patients with hepatic/ digestive tract disorder and confirm their usefulness as predictors of diagnosis; and to investigate correlations between the rare mutation (and gene amplification etc) and the subsequent treatment effect.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of rare mutation
Key secondary outcomes
Overall survival (OS)
Progression free survival (PFS)
Tumor marker assessment
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)Patients for whom examination for hepatic /digestive tract disorder is selected in clinical practice
2)Patients who have provided written informed consent for participation in this study
Key exclusion criteria
Patients judged by the principal investigator or subinvestigator to be unsuitable for participation for any other reason (to ensure the safe conduct of this study)
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | HIDEAKI |
| Middle name | |
| Last name | KINUGASA |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.
Division name
GASTROENTEROLOGY
Zip code
700-8558
Address
2-5-1 SHIKATA-CHO KITA-KU OKAYAMA CITY
TEL
086-235-7218
gyacy14@gmail.com
Public contact
Name of contact person
| 1st name | HIDEAKI |
| Middle name | |
| Last name | KINUGASA |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.
Division name
GASTROENTEROLOGY
Zip code
700-8558
Address
2-5-1 SHIKATA-CHO KITA-KU OKAYAMA CITY
TEL
086-235-7218
Homepage URL
gyacy14@gmail.com
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.
Institute
Department
Personal name
Funding Source
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.
Address
2-5-1 SHIKATA-CHO KITA-KU OKAYAMA CITY
Tel
086-235-7218
mae6605@adm.okayama-u.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
| 2013 | Year | 09 | Month | 19 | 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
| 2013 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2013 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2013 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
observe
Management information
Registered date
| 2013 | Year | 09 | Month | 19 | Day |
Last modified on
| 2021 | Year | 03 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013803
| 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 |
