UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042331 |
|---|---|
| Receipt number | R000048320 |
| Scientific Title | Prospective observational study on treatment strategy for pancreatic cancer focusing on the chemotherapy response |
| Date of disclosure of the study information | 2020/11/05 |
| Last modified on | 2023/05/06 20:30:04 |
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Basic information
Public title
Prospective observational study on treatment strategy for pancreatic cancer focusing on the chemotherapy response
Acronym
Prospective observational study on treatment strategy for pancreatic cancer focusing on the chemotherapy response
Scientific Title
Prospective observational study on treatment strategy for pancreatic cancer focusing on the chemotherapy response
Scientific Title:Acronym
Prospective observational study on treatment strategy for pancreatic cancer focusing on the chemotherapy response
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of treatment strategy for pancreatic cancer focusing on the transition of CA19-9 as a biomarker for chemotherapy response
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
relationship between the transition of CA19-9 and clinical outcome
Key secondary outcomes
Overall survival
Progression free survival
Recurrence free survival
Histopathological response rate for chemotherapy
Complications or adverse effects due to chemotherapy
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.In the case where the primary lesion is confirmed to be pancreatic cancer by histology, cytology, or imaging examination
2.Initial treatment case
3.Performance status (ECOG) is 0 or 1
4.Cases in which consent for the participation in this study was obtained by the signature of the person before registration
5.Equal to or more than 20 years old
6.Gender:Regardless
7.Admission or outpatient:Regardless
Key exclusion criteria
1.Cases without consent for the participation in this study
2.Cases with pregnancy or possibility of pregnancy
3.Cases with pulmonary dysfunction(arterial PaO2<=70mmHg)
4.Cases with cardiac dysfunction(New York Heart Association classification>=Class 3)
5.Cases with liver dysfunction(Child Pugh C)
6.Cases with renal dysfunction(patients with hemodialysis)
7.Cases with active infection
8.History of neurologically or psychologically significant disease, and cases with complications
9.Patients with best supportive care(BSC)
10.Patients whom principal investigator judged inappropriate for subjects of the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takahito |
| Middle name | |
| Last name | Yagi |
Organization
Okayama University Graduate School of Medicine
Division name
Department of hepato-biliary-pancreatic surgery
Zip code
700-8558
Address
2-5-1, Shikatacho, Kita-ku, Okayama city
TEL
086-235-7257
liver@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Kokichi |
| Middle name | |
| Last name | Miyamoto |
Organization
Okayama University Graduate School of Medicine
Division name
Department of hepato-biliary-pancreatic surgery
Zip code
700-8558
Address
2-5-1, Shikatacho, Kita-ku, Okayama city
TEL
086-235-7257
Homepage URL
kokichi.m100@gmail.com
Sponsor or person
Institute
Department of hepato-biliary-pancreatic surgery, Okayama University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB of Okayama University
Address
2-5-1, Shikatacho, Kita-ku, Okayama
Tel
086-235-6938
mae6605@adm.okayama-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 | 11 | 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
76
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2020 | Year | 11 | Month | 02 | Day |
Last modified on
| 2023 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048320
| 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 |
