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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002384
Receipt No. R000002910
Scientific Title Metabolome analysis of cachexia and its circadian rhythms in patients with advanced pancreatic cancer.
Date of disclosure of the study information 2009/10/01
Last modified on 2017/06/04

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Basic information
Public title Metabolome analysis of cachexia and its circadian rhythms in patients with advanced pancreatic cancer.
Acronym Metabolome analysis in advanced pancreatic cancer patients with cachexia.
Scientific Title Metabolome analysis of cachexia and its circadian rhythms in patients with advanced pancreatic cancer.
Scientific Title:Acronym Metabolome analysis in advanced pancreatic cancer patients with cachexia.
Region
Japan

Condition
Condition advanced pancreatic cancer
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To explore the metabolites on cachexia in patients with advanced pancreatic cancer by metabolom analysis.
Basic objectives2 Others
Basic objectives -Others Biomarker
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes The metabolites on cachexia by metabolom analysis
Key secondary outcomes The circadian rhythms of the metabolites on cachexia

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. histologically or cytologically diagnosed adenocarcinoma or adenosquamous carcinoma
2. locally advanced or metastatic pancreatic cancer
3. A) patients without cachexia
B) patients with cachexia
4. age of 20 years or older
5. adequate baseline organ function
6. patients provided written informed consent
Key exclusion criteria 1. resectable pancreatic cancer
2. pancreatic neuroendcrine carcinoma
3. chemotherapy within 1 week
4. surgery within 1 month
5. deffinitive radiotherapy within 1 month
6. palliative radiotherapy within 2 weeks
7. uncontroled infection
8. uncontroled diabetic mellitus
9. condition that required corticosteroid
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hironobu Minami
Organization Kobe University Graduate School of Medicine
Division name Medical Oncology
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL 0783825111
Email hminami@ncc.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yutaka Fujiwara
Organization Kobe University Graduate School of Medicine
Division name Medical Oncology
Zip code
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL 0783825111
Homepage URL
Email fu_ji_@yahoo.co.jp

Sponsor
Institute Medical Oncology, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization Medical Oncology, Kobe University Graduate School of Medicine
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
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
2009 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2009 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2012 Year 09 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2014 Year 10 Month 01 Day

Other
Other related information Case controle sampling
Prospective study

Management information
Registered date
2009 Year 08 Month 25 Day
Last modified on
2017 Year 06 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002910

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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