UMIN-CTR Clinical Trial

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
Email	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
Email	yoshimako10@sapmed.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052287