UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009592 |
|---|---|
| Receipt number | R000011043 |
| Scientific Title | Prospective study of the correlation between expression of Corticotropin-Releasing Hormone and prognosis of pancreatic tumor, and QOL survey |
| Date of disclosure of the study information | 2012/12/20 |
| Last modified on | 2015/03/09 08:51:25 |
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Basic information
Public title
Prospective study of the correlation between expression of Corticotropin-Releasing Hormone and prognosis of pancreatic tumor, and QOL survey
Acronym
Prospective study of the correlation between expression of CRH and prognosis of pancreatic tumor, and QOL survey
Scientific Title
Prospective study of the correlation between expression of Corticotropin-Releasing Hormone and prognosis of pancreatic tumor, and QOL survey
Scientific Title:Acronym
Prospective study of the correlation between expression of CRH and prognosis of pancreatic tumor, and QOL survey
Region
| Japan |
Condition
Condition
pancreatic tumor
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A primary objective is evaluate the correlation between expression of CRH and the prognosis of pancreatic tumor. And, also carried out stress evaluation of QOL at the same time
Basic objectives2
Others
Basic objectives -Others
Prospective study to evaluating the CRH expression after observation period.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
evaluate the correlation of disease free survival and CRH expression
Key secondary outcomes
evaluate the correlation of overall Survival, progression-Free Survival, QOL
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. Possibly resectable of Pancreatic tumor
2. No previous therapy
3. ECOG PS of 0 or 1
4. tolerable function of bone marrow, liver and kidney..
5. Possible oral intake.
6. written informed consent
7. over 20 years old
Key exclusion criteria
1. Pulmonary fibrosis or interstitial pneumonitis
2. Patients expectd R2 resection
3. Patients with synclonous double cancer
4. Active infection
5. HBs Ag positive
6. Patients requiring the administration of flucytosine, phenytoin or warfarin potassium
7. Patients who are pregnant or possibly pregnant.
8.The patient judged to be unsuitable by attending doctor
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Unno |
Organization
Tohoku University
Division name
Department of surgery
Zip code
Address
1-1 Seiryomachi, Aobaku, Sendai
TEL
022-717-7205
m_unno@surg1.med.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kei Nakagawa |
Organization
Tohoku University Graduate School of Medicine
Division name
Integrated Surgery and Oncolog
Zip code
Address
1-1 Seiryomachi, Aobaku, Sendai
TEL
022-717-7205
Homepage URL
kein_h11@surg1.med.tohoku.ac.jp
Sponsor or person
Institute
Department of surgery, Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
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
| 2012 | Year | 12 | 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
| 2012 | Year | 11 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 12 | Month | 20 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
now recruiting
Management information
Registered date
| 2012 | Year | 12 | Month | 20 | Day |
Last modified on
| 2015 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011043
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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