UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045799 |
|---|---|
| Receipt number | R000052287 |
| Scientific Title | Survey of clinical practice and prognostic factors for unresectable locally advanced pancreatic cancer: Multicenter prospective observational study |
| Date of disclosure of the study information | 2021/10/20 |
| Last modified on | 2022/11/10 01:38:36 |
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Basic information
Public title
Survey of clinical practice and prognostic factors for unresectable locally advanced pancreatic cancer: Multicenter prospective observational study
Acronym
HOPS-UR02
Scientific Title
Survey of clinical practice and prognostic factors for unresectable locally advanced pancreatic cancer: Multicenter prospective observational study
Scientific Title:Acronym
HOPS-UR02
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Survey of clinical practice and prognostic factor for locally advanced unresectable pancreatic cancer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
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. Unresectable locally advanced pancreatic cancer has been diagnosed by chest CT and abdominal contrast CT.
2. Invasive pancreatic ductal carcinoma (adenocarcinoma, adenosquamous carcinoma, mucinous carcinoma, anaplastic carcinoma) has been diagnosed by histological or cytological examination.
3. Distant metastasis corresponding to M1 is not found on the image.
d. First-line treatment (no history of treatment for pancreatic cancer).
e. The age of registration date is 20 years or older.
f. Written consent of the individual or his / her representative has been obtained for participation in the study.
Key exclusion criteria
1. Your physician determines that you are unsuitable for enrollment in the study.
2. Contrast-enhanced CT imaging is not possible due to drug allergy to iodine-based contrast media. However, contrast-enhanced CT imaging is not possible with steroid prophylactic administration.
3. Pleural effusion and ascites for which metastasis cannot be ruled out are observed on chest CT and abdominal / pelvic contrast CT.
4. Contrast-enhanced MRI shows a liver mass that metastasis cannot be ruled out.
5. Active double cancer (simultaneous double cancer). However, lesions such as carcinoma in situ or intramucosal cancer that are judged to be cured by topical therapy are not included in active double cancer.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8648
Address
West 5, North 14, Kita-ku, Sapporo
TEL
011-716-1161
mkuwatan@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Yoshida |
Organization
Sapporo Medical University Hospital
Division name
Department of clinical Oncology
Zip code
060-8543
Address
West 16, South 1, Chuo-Ku, Sapporo
TEL
011-611-2111
Homepage URL
yoshimako10@sapmed.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
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
Hokkaido University Certified Review Board
Address
West 5, North 14, Kita-ku, Sapporo, Hokkaido
Tel
011-706-7934
recjimu@huhp.hokudai.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 | 10 | Month | 20 | 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
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Each research director and research coordinator use the EDC (Electronic Data Capture) system "NorthNet" for researchers handled by the Clinical Research and Development Center of Hokkaido University Hospital using the Internet line. Accumulate. Collected data will be analyzed at the data management facility shown in the research implementationsystem.
Management information
Registered date
| 2021 | Year | 10 | Month | 20 | Day |
Last modified on
| 2022 | Year | 11 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052287
