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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000041309
Receipt No. R000047172
Scientific Title A study on the relationship of hypoxic region and therapeutic effect in pancreatic cancer
Date of disclosure of the study information 2020/10/01
Last modified on 2020/08/04

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Basic information
Public title A study on the relationship of hypoxic region and therapeutic effect in pancreatic cancer
Acronym A study on the relationship of hypoxic region and therapeutic effect in pancreatic cancer
Scientific Title A study on the relationship of hypoxic region and therapeutic effect in pancreatic cancer
Scientific Title:Acronym A study on the relationship of hypoxic region and therapeutic effect in pancreatic cancer
Region
Japan

Condition
Condition pancreatic cancer
Classification by specialty
Radiology Adult
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To elucidate the pathogenesis of hypoxic regions of pancreatic cancer that are resistant to treatment, we used hypoxic PET and pathology findings, predicting the effects of chemoradiotherapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between hypoxic regions and 2-year overall survival
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Hypoxic PET
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
80 years-old >
Gender Male and Female
Key inclusion criteria The pancreatic cancer patients who are going to receive chemoradiotherapy at Kyoto University Hospital
Key exclusion criteria 1) Patients in extremely poor general condition.
2) Patients who have a history of previous abdominal radiotherapy that overlaps with the irradiation field of the current pancreatic cancer.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Mizowaki
Organization Kyoto University Graduate School of Medicine
Division name Radiation Oncology and Imaging Applications
Zip code 6068507
Address 54 Shougoin-kawaramachi sakyoku Kyoto city Kyoto prefecture Japan
TEL 075-751-3762
Email mizo@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name Michio
Middle name
Last name Yoshimura
Organization Kyoto University Graduate School of Medicine
Division name Radiation Oncology and Imaging Applications
Zip code 6068507
Address 54 Shougoin-kawaramachi sakyoku Kyoto city Kyoto prefecture Japan
TEL 075-751-3762
Homepage URL
Email myossy@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
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 Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address 54 Shougoin-kawaramachi sakyoku Kyoto city Kyoto prefecture Japan
Tel 075-753-4680
Email ethcom@kuhp.kyoto-u.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
2020 Year 10 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 Preinitiation
Date of protocol fixation
2020 Year 08 Month 04 Day
Date of IRB
Anticipated trial start date
2020 Year 10 Month 01 Day
Last follow-up date
2026 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 08 Month 04 Day
Last modified on
2020 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047172

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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