UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002384 |
|---|---|
| Receipt number | 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 | 2019/12/25 17:36:52 |
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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 | Hironobu |
| Middle name | |
| Last name | Minami |
Organization
Kobe University Graduate School of Medicine
Division name
Medical Oncology
Zip code
50-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
0783825111
hminami@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Fujiwara |
Organization
Kobe University Graduate School of Medicine
Division name
Medical Oncology
Zip code
50-0017
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL
0783825111
Homepage URL
fu_ji_@yahoo.co.jp
Sponsor or person
Institute
Medical Oncology, Kobe University Graduate School of Medicine
Institute
Department
Personal name
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
Kobe university
Address
7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
Tel
078-382-5111
rinri@med.kobe-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
| 2009 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
None
Publication of results
Published
Result
URL related to results and publications
https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0113259
Number of participants that the trial has enrolled
21
Results
Levels of paraxanthine remained markedly lower in the cohort with cachexia at all measurement points. Besides, median IL-6 and TNF levels appeared higher and leptin concentration appeared lower in the cachexia group, albeit without statistical significance.
Results date posted
| 2019 | Year | 12 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Cancer cachexia is a multifactorial syndrome characterized by progressive loss of weight and muscle atrophy. Using metabolomics, we investigated serum markers and their intra-day variation in advanced pancreatic cancer patients with cachexia.
Participant flow
Twenty-one patients were enrolled in total.
Adverse events
Nothing paticular
Outcome measures
Blood samples collected at 6:30 AM, 11:30 AM, 4:30 PM, and 9:30 PM were analyzed using metabolomics, and serum levels of IL-6, TNF, and leptin were measured and compared between the two groups
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2009 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2009 | Year | 09 | Month | 01 | Day |
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
| 2019 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002910
