UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034022 |
|---|---|
| Receipt number | R000038787 |
| Scientific Title | Prospective study to identify prognostic markers of pancreatic cancer |
| Date of disclosure of the study information | 2018/11/01 |
| Last modified on | 2018/10/31 11:09:00 |
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Basic information
Public title
Prospective study to identify prognostic markers of pancreatic cancer
Acronym
Identification of preoperative and postoperative prognostic markers of pancreatic cancer
Scientific Title
Prospective study to identify prognostic markers of pancreatic cancer
Scientific Title:Acronym
Identification of preoperative and postoperative prognostic markers of pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to investigate the use of the preoperative and postoperative prognostic factors as useful markers for the poor prognosis of pancreatic cancer patients.
Basic objectives2
Others
Basic objectives -Others
To determine whether the prognostic factors are useful to predict the prognosis of pancreatic cancer patients
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Overall survival
Key secondary outcomes
Disease-Free Survival
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) more than 20 years old and less than 90 years old
(2) pancreatic cancer patients newly diagnosed and previously untreated
(3) surgically-adapted pancreatic cancer patients
Key exclusion criteria
(1) pancreatic cancer patients previously treated
(2) non-surgically-adapted pancreatic cancer patients
(3) patients who were suffering from any kind of malignancies including pancreatic cancer within 5 years
(4) sever renal or liver dysfunction
(5) individuals who did not accept informed consent
(6) unsuitable individuals for this clinical study
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Keisuke Taniuchi |
Organization
Kochi Medical School Hospital, Kochi University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kohasu, Oko-cho, Nankoku, Kochi
TEL
088-880-2338
ktaniuchi@kochi-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Keisuke Taniuchi |
Organization
Kochi Medical School Hospital, Kochi University
Division name
Department of Gastroenterology and Hepatology
Zip code
Address
Kohasu, Oko-cho, Nankoku, Kochi
TEL
088-880-2338
Homepage URL
ktaniuchi@kochi-u.ac.jp
Sponsor or person
Institute
Department of Gastroenterology and Hepatology, Kochi Medical School Hospital, Kochi University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanagawa Cancer Center
Tokyo Metropolitan Tama Medical Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2018 | Year | 11 | 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
Open public recruiting
Date of protocol fixation
| 2018 | Year | 09 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2025 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
| 2025 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2025 | Year | 12 | Month | 31 | Day |
Other
Other related information
This study was approved by the ethical review boards of Kochi Medical School, Kanagawa Cancer Center and Tokyo Metropolitan Tama Medical Center prior to patient recruitment. Written informed consent was acquired from each patient prior to initiation.
Management information
Registered date
| 2018 | Year | 09 | Month | 04 | Day |
Last modified on
| 2018 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038787
