UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040276 |
|---|---|
| Receipt number | R000045847 |
| Scientific Title | Research of serum biomarker for pancreatic or bile duct cancers using peptide analysis |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2020/04/30 10:32:16 |
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Basic information
Public title
Research of serum biomarker for pancreatic or bile duct cancers using peptide analysis
Acronym
Research of biomarker for pancreatic or bile duct cancers
Scientific Title
Research of serum biomarker for pancreatic or bile duct cancers using peptide analysis
Scientific Title:Acronym
Research of biomarker for pancreatic or bile duct cancers
Region
| Japan |
Condition
Condition
pancreatic cancer, bile duct cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Research of biomarkers for pancreatic or bile duct cancers using peptide analysis.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Peptide analysis using BLOTCHIP
Key secondary outcomes
1 Pathological diagnosis
2 Imaging diagnosis
3 Clinical stage
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
All patients diagnosed as pancreatic or bile duct cancers at Toyama University Hospital with written informed consent.
Key exclusion criteria
1 Patients with high risk of complications from blood sampling.
2 Patients who do not or can not give informed consent.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takahara |
| Middle name | |
| Last name | Terumi |
Organization
University of Toyama
Division name
Department of Advanced Technology for Gastroenterological Cancer Therapy
Zip code
930-0194
Address
2630 sugitani, Toyama city, Toyama, Japan
TEL
076-434-7440
taka@med.u-toyama.ac.jp
Public contact
Name of contact person
| 1st name | Tajiri |
| Middle name | |
| Last name | Kazuto |
Organization
University of Toyama
Division name
Third Department of Inetrnal Medicine
Zip code
930-0194
Address
2630 Sugitani, Toyama city, Toyama, Japan
TEL
076-431-7301
Homepage URL
tajikazu@med.u-toyama.ac.jp
Sponsor or person
Institute
Universtiy of Toyama
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethics Committee, University of Toyama
Address
2630 sugitani, Toyama city, Toyama, Japan
Tel
076-415-8857
rinri@adm.u-toyama.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
| 2020 | Year | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 07 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Research of serum biomarker for pancreatic or bile duct cancers using peptide analysis
Management information
Registered date
| 2020 | Year | 04 | Month | 30 | Day |
Last modified on
| 2020 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045847
