UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045027 |
|---|---|
| Receipt number | R000050821 |
| Scientific Title | Prospective observational study to establish the indications for staging laparoscopy in pancreatic cancer |
| Date of disclosure of the study information | 2021/08/01 |
| Last modified on | 2021/07/31 17:28:06 |
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Basic information
Public title
Prospective observational study to establish the indications for staging laparoscopy in pancreatic cancer
Acronym
Prospective observational study to establish the indications for staging laparoscopy in pancreatic cancer
Scientific Title
Prospective observational study to establish the indications for staging laparoscopy in pancreatic cancer
Scientific Title:Acronym
Prospective observational study to establish the indications for staging laparoscopy in pancreatic cancer
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To establish the indications for staging laparoscopy in pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of risk factors predicting radiologically undetectable micrometastases in pancreatic cancer
Key secondary outcomes
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 who are histologically or cytologically diagnosed as pancreatic cancer
(2) No distant metastasis in radiological imaging tests at the initial diagnosis
(3) Pancreatic cancer patients determined to have indications of treatment intended for resection
Key exclusion criteria
(1) Patients who are not histologically or cytologically diagnosed as pancreatic cancer
(2) Distant metastasis in radiological imaging tests
(3) Patients with concurrent active multiple cancers at the enrollment
(4) Patients with poor general condition who are determined to have no indication for staging laparoscopy or treatment intended for resection
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Masamichi |
| Middle name | |
| Last name | Mizuma |
Organization
Tohoku University
Division name
Department of Surgery
Zip code
980-8574
Address
1-1 Seiryomachi, Aobaku, Sendai, Japan
TEL
022-717-7205
masamichi@surg.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Masamichi |
| Middle name | |
| Last name | Mizuma |
Organization
Tohoku University
Division name
Department of Surgery
Zip code
980-8574
Address
1-1 Seiryomachi, Aobaku, Sendai, Japan
TEL
022-717-7205
Homepage URL
masamichi@surg.med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
KUROKAWA CANCER RESEARCH FOUNDATION
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku University
Address
1-2 Seiryomachi, Aobaku, Sendai, Japan
Tel
022-717-7056
med-kenkyo@grp.tohoku.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
| 2021 | Year | 08 | 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
| 2021 | Year | 06 | Month | 04 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 27 | Day |
Last follow-up date
| 2026 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2021 | Year | 07 | Month | 31 | Day |
Last modified on
| 2021 | Year | 07 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050821
