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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000009592
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email kein_h11@surg1.med.tohoku.ac.jp

Sponsor
Institute Department of surgery, Tohoku University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011043


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