UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036413 |
|---|---|
| Receipt number | R000041483 |
| Scientific Title | A Novel diagnostic method using methylation of the cysteine dioxygenase 1 gene promoter DNA-Establishment of pancreatic fuluid DNA cytology test for pancreatic ductal adenocarcinoma |
| Date of disclosure of the study information | 2019/04/04 |
| Last modified on | 2019/04/04 20:25:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A Novel diagnostic method using methylation of the cysteine dioxygenase 1 gene promoter DNA-Establishment of pancreatic fuluid DNA cytology test for pancreatic ductal adenocarcinoma
Acronym
A prospective case series study on pancreatic fuluid DNA cytology test for pancreatic ductal adenocarcinoma
Scientific Title
A Novel diagnostic method using methylation of the cysteine dioxygenase 1 gene promoter DNA-Establishment of pancreatic fuluid DNA cytology test for pancreatic ductal adenocarcinoma
Scientific Title:Acronym
A prospective case series study on pancreatic fuluid DNA cytology test for pancreatic ductal adenocarcinoma
Region
| Japan |
Condition
Condition
Pancreatic ductal adenocarcinoma
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the usefulness of pancreatic fuluid cytology by detecting CDO1 gene methylation in patients for pancreatic ductal adenocarcinoma
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance rate between conventional cytology and DNA cytology
Key secondary outcomes
Concordance rate between histological diagnosis and DNA cytology
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
1) Patients suspected with pancreatic ductal adenocarcinoma
2) Patients who had a high-risk factor of PDAC including chronic pancreatitis of pancreatic ductal adenocarcinoma
3) Patients who underwent ERP for a definitive diagnosis of the pancreatic ductal adenocarcinoma.
4) Patients who underwent endoscopic EUS-FNA for a definitive diagnosis of the pancreatic ductal adenocarcinoma.
5) With written informed consent before examination
Key exclusion criteria
Patients without preoperative informed consent
Target sample size
350
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Watanabe |
Organization
Kitasato University School of Medicine
Division name
Department of Surgery
Zip code
252-0374
Address
1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
gekaw@med.kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Nishizawa |
Organization
Kitasato University School of Medicine
Division name
Department of Surgery
Zip code
252-0374
Address
1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
TEL
042-778-8111
Homepage URL
dm14018v@st.kitasato-u.ac.jp
Sponsor or person
Institute
Department of Surgery, Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Kitasato University School of Medicine
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
Kitasato University School of Medicine Ethics Committee
Address
1-15-1 Kitasato, Minamiku, Sagamihara, Kanagawa, Japan
Tel
042-778-8111
rinri@med.kitasato-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
| 2019 | Year | 04 | Month | 04 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: A prospective case series study
Management information
Registered date
| 2019 | Year | 04 | Month | 04 | Day |
Last modified on
| 2019 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041483
