UMIN-CTR Clinical Trial

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
Email	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
Email	gyacy14@gmail.com

Sponsor
Institute	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000013803