UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005493 |
|---|---|
| Receipt number | R000006505 |
| Scientific Title | Impact of inflammatory molecules on disease progression in advanced pancreatobiliary cancer |
| Date of disclosure of the study information | 2012/01/01 |
| Last modified on | 2023/11/01 09:02:38 |
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Basic information
Public title
Impact of inflammatory molecules on disease progression in advanced pancreatobiliary cancer
Acronym
Study of inflammation and disease progression in advanced pancreatobiliary cancer
Scientific Title
Impact of inflammatory molecules on disease progression in advanced pancreatobiliary cancer
Scientific Title:Acronym
Study of inflammation and disease progression in advanced pancreatobiliary cancer
Region
| Japan |
Condition
Condition
pancreatic cancer, biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate serum levels of inflammatory molecules in cachexia and tumor progression of pancreatobiliary cancer
Basic objectives2
Others
Basic objectives -Others
To evaluate the expression of inflamtory molecules of tumor or liver in cachexia and tumor progression of pancreatobiliary cancer
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
serum level
mRNA expression
immunohistochemistry
metabolome analysis
phsopho-protein analysis
cachexia
body composition
symptoms
clinical data
Key secondary outcomes
the distribution of KRAS mutation
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
Liver biopsy
Tumor biopsy
Blood sample collection
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) Clinically diagnosed as advanced pancreatobiliary cancer
2) The percutaneous biopsy to intrahepatic tumor was required
3) Age >=20
4) Systemic chemotherapy was planned
5) With written informed consent
Key exclusion criteria
1) History of treatment with corticosteroids(oral intake or intravenously) for chronic inflammatory disease, such as interstitial lung disease, collagen disease, and Crohn disease
2) Treatment with corticosteroids (oral intake or intravenously) for allergic disease within four weeks
3) Surgical treatment within four weeks
4) Paralytic or mechanical bowel obstruction
5) Simultaneous or metachronous double cancers
6) Any other patient whom the physician in charge of the study judges to be unsuitable
Target sample size
168
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Mitsunaga |
Organization
National Cancer Center Hospital East
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa Chiba, 277-8577, Japan
TEL
04-7133-1111
smitsuna@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Mitsunaga |
| Middle name | |
| Last name | Shuichi |
Organization
National Cancer Center Hospital East
Division name
Department of Hepatobiliary and Pancreatic Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa Chiba, 277-8577, Japan
TEL
04-7133-1111
Homepage URL
smitsuna@east.ncc.go.jp
Sponsor or person
Institute
Division of Hepatobiliary and Pancreatic Oncology, National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
Ministry of Health, Labour and Welfare
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
Chuoku Tsukiji 5-1-1, Tokyo, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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
| 2012 | Year | 01 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.ncbi.nlm.nih.gov/pubmed/23591198
Publication of results
Partially published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/23591198
Number of participants that the trial has enrolled
60
Results
High IL-6 and IL-1b levels were poor prognostic factors for overall survival in a multivariate analysis (P = 0.011 and P = 0.048, respectively). Patients with both a high IL-6 level and a high IL-1b level exhibited shortened overall and progression-free survival, a reduction in the tumour control rate, and a high dose intensity of GEM compared with patients with low levels of both IL-6 and IL-1b.
Results date posted
| 2019 | Year | 11 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Treatment-naive patients with advanced PC and no obvious infections were eligible for enrolment. All of the patients were scheduled to undergo systemic chemotherapy. Serum pro-inflammatory cytokines were measured using an electro-chemiluminescence assay method before chemotherapy.
Participant flow
Sixty patients who received GEM were included in the analysis.
Adverse events
not available
Outcome measures
prognosis, dose intensity of gemcitabine
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2011 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 09 | Day |
Anticipated trial start date
| 2011 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Analysis in progress
Management information
Registered date
| 2011 | Year | 04 | Month | 23 | Day |
Last modified on
| 2023 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006505
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