UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035454 |
|---|---|
| Receipt number | R000040393 |
| Scientific Title | Observational cohort study of clinically diagnosed unresectable pancreatic cancer patients; A multicenter retrospective, questionnaire analysis in Hokkaido Pancreatic Cancer Study Group (HOPS). |
| Date of disclosure of the study information | 2019/01/05 |
| Last modified on | 2019/01/05 14:03:09 |
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Basic information
Public title
Observational cohort study of clinically diagnosed unresectable pancreatic cancer patients; A multicenter retrospective, questionnaire analysis in Hokkaido Pancreatic Cancer Study Group (HOPS).
Acronym
HOPS-UR
Scientific Title
Observational cohort study of clinically diagnosed unresectable pancreatic cancer patients; A multicenter retrospective, questionnaire analysis in Hokkaido Pancreatic Cancer Study Group (HOPS).
Scientific Title:Acronym
HOPS-UR
Region
| Japan |
Condition
Condition
Pancreatic adenocarcinoma (PDAC), unresectable (UR)
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hematology and clinical oncology | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to evaluate outcomes of patients who were clinically diagnosed as UR-PDAC.
Basic objectives2
Others
Basic objectives -Others
To assess the outcomes of patients who were clinically diagnosed as UR-PDAC and were treated in tertiary referral hospitals around Hokkaido prefecture.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Conversion rate to radical surgeries
Key secondary outcomes
Sequential treatment regimens and overall survival (OS)
Base
Study type
Others,meta-analysis etc
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 were defined as unersectable (UR-) and were ineligible for these two studies by HOPS central MDCT review.
2) Pathologically or cytologically proven diagnosis of pancreas cancer.
3) Patients of age =>20
4) Performance Status:0-1 (ECOG)
5) Adequate oral intake
6) Good main organ function
Key exclusion criteria
Patients who were defined as resectable (R-) or borderline resectable (BR-) by HOPS central MDCT review.
Target sample size
66
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasutoshi Kimura |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
Address
S1 W16, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan
TEL
011-611-2111
kimuray@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasutoshi Kimura |
Organization
Sapporo Medical University
Division name
Department of Surgery, Surgical Oncology and Science
Zip code
Address
S1 W16, Chuo-ku, Sapporo, Hokkaido 060-8543, Japan
TEL
011-611-2111
Homepage URL
http://sapmed-surg1.jp/gairai/optout.shtml
kimuray@sapmed.ac.jp
Sponsor or person
Institute
Department of Surgery, Surgical Oncology and Science, Sapporo Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Surgery, Surgical Oncology and Science, Sapporo Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
| 2019 | Year | 01 | Month | 05 | 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
Completed
Date of protocol fixation
| 2016 | Year | 05 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 06 | Month | 13 | Day |
Last follow-up date
| 2018 | Year | 04 | Month | 28 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 26 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 29 | Day |
Date analysis concluded
| 2019 | Year | 01 | Month | 31 | Day |
Other
Other related information
Background information: age, sex, medical history,
Non-surgical treatment information: treatment, drug used, treatment period, treatment effect judgment
Surgical information: operative method, operation time, amount of bleeding
Postoperative information: postoperative complication, postoperative hospital stay
Information on postoperative information: presence or absence of postoperative adjuvant chemotherapy (drug, duration) Presence or absence of recurrence (presence or absence of treatment, content, duration), presence / absence of death, cause of death
Management information
Registered date
| 2019 | Year | 01 | Month | 05 | Day |
Last modified on
| 2019 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040393
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
