UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051856 |
|---|---|
| Receipt number | R000057767 |
| Scientific Title | Prospective Study on relationship between CD73 expression in biliary tract cancer and response to anticancer drugs and the underlying biological mechanisms |
| Date of disclosure of the study information | 2023/08/07 |
| Last modified on | 2023/08/07 20:41:58 |
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Basic information
Public title
Prospective Study on relationship between CD73 expression in biliary tract cancer and response to anticancer drugs and the underlying biological mechanisms
Acronym
Prospective Study on relationship between CD73 expression in biliary tract cancer and the underlying biological mechanisms
Scientific Title
Prospective Study on relationship between CD73 expression in biliary tract cancer and response to anticancer drugs and the underlying biological mechanisms
Scientific Title:Acronym
Prospective Study on relationship between CD73 expression in biliary tract cancer and its progression and prognosis, and the underlying biological mechanisms
Region
| Japan |
Condition
Condition
Biliary tract cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the impact of CD73 expression in biliary tract cancer on response to anticancer therapy and the mechanisms underlying.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between CD73 expression in the biliary tract cancer specimen and response to anticancer therapy
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed as pathologically (cytology/biospy/surgery) having biliary tract cancer
2) Patients giving informed consent to anticipating in this study by oneself/a legal representative
Key exclusion criteria
1) Patients diagnosed as having another malignancy within the past 3 years
2) Patients deemed inappropriate by the investigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Gastroenterology and Hepatology
Zip code
060-8648
Address
West 5, North 14, Kita-ku, Sapporo, Hokkaido
TEL
011-716-1161
mkuwatan@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Kuwatani |
Organization
Hokkaido University Hospital
Division name
Gastroenterology and Hepatology
Zip code
060-8648
Address
West 5, North 14, Kita-ku, Sapporo, Hokkaido
TEL
011-716-1161
Homepage URL
mkuwatan@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
West 5, North 14, Kita-ku, Sapporo, Hokkaido
Tel
81-11-706-7636
crjimu@huhp.hokudai.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
| 2023 | Year | 08 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 06 | Month | 28 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 28 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Association of CD73/39 and CD73/CD39-related metabolite (ATP, ADP, AMP, adenosine) concentrations in serum/bile/duodenal fluid of biliary tract cancer patients with anticancer treatment efficacy and overall/progression-free survival
2) Association between CD39 expression in pathological specimens of biliary tract cancer and response to anticancer therapy
3) Association between CD73/39 expression and overall/progression-free survival in pathological specimens of biliary tract cancer
4) Elucidation of related mechanisms: CD73/CD39 expression and CD73/CD39-related metabolite (ATP, ADP, AMP, adenosine) receptor expression, vascular proliferation-related (VEGF, VEGFR-related), epithelial-mesenchymal transition-related factors (E-cadherin, vimentin, ERK-related protein) expression, immune cell counts and immune responses in pathological specimens ), immune cell count and immune cell adenosine receptors. CD73/CD39 and CD73/CD39-related metabolite concentrations in serum and bile/duodenal fluid in relation to immune cell counts and immune cell function
Management information
Registered date
| 2023 | Year | 08 | Month | 07 | Day |
Last modified on
| 2023 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057767
