UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044430 |
|---|---|
| Receipt number | R000050755 |
| Scientific Title | Biomarker analysis associated with diagnostic, recurrence, and therapeutic effects in pancreatic cancer and biliary tract cancer |
| Date of disclosure of the study information | 2021/06/04 |
| Last modified on | 2021/06/04 13:46:52 |
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Basic information
Public title
Biomarker analysis associated with diagnostic, recurrence, and therapeutic effects in pancreatic cancer and biliary tract cancer
Acronym
Biomarker analysis associated with diagnostic, recurrence, and therapeutic effects in pancreatic cancer and biliary tract cancer
Scientific Title
Biomarker analysis associated with diagnostic, recurrence, and therapeutic effects in pancreatic cancer and biliary tract cancer
Scientific Title:Acronym
Biomarker analysis associated with diagnostic, recurrence, and therapeutic effects in pancreatic cancer and biliary tract cancer
Region
| Japan |
Condition
Condition
Pancreatic cancer
Biliary tract cancer
Classification by specialty
| Medicine in general | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Analyze the expression of small RNAs associated with diagnostic, recurrence, and therapeutic effects in patients diagnosed with pancreatic cancer and biliary tract cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Small RNAs associated with diagnosis
2) Investigate the relationship between the following items and the expression status of small RNAs
<Patient background>
Patient age, gender, primary site, stage, treatment method and information on results and course, information on recurrence and metastasis, information on unfollowable or termination due to transfer, etc.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Diagnosed or clinically suspected pancreatic cancer or biliary tract cancer patients.
2) Scheduled treatment at our hospital
3) The consent has been obtained
4) 20 years old and over
Key exclusion criteria
1) Have a history or complication of other cancers
2) Judged as lacking consent due to dementia or mental illness
3)Patients who have decided inappropriate to include in this study by the investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Naoto |
| Middle name | |
| Last name | Gotohda |
Organization
National Cancer Center Hospital East
Division name
Department of Hepatobiliary and Pancreatic Surgery
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa city, Chiba, Japan
TEL
04-7133-1111
ngotohda@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Morie |
| Middle name | |
| Last name | Nishiwaki |
Organization
MiRTeL Co.Ltd.
Division name
Research and Development Division
Zip code
734-0001
Address
1-2-10 Deshio Minami-ku, Hiroshima city, Hiroshima, Japan
TEL
082-546-9797
Homepage URL
kenkyu@mirtel.co.jp
Sponsor or person
Institute
MiRTeL Co.Ltd.
Institute
Department
Personal name
Funding Source
Organization
MiRTeL Co.Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital East
Address
6-5-1 Kashiwanoha, Kashiwa city, Chiba, Japan
Tel
04-7133-1111
irst@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
| 2021 | Year | 06 | Month | 04 | 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
| 2021 | Year | 03 | Month | 22 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 20 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 04 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) Small RNAs related with diagnosis of malignancy
2) Relationship between the status of small RNAs and the following clinicopathological factors: age, sex, tumor site, stage, therapy, clinical course, recurrence, metastasis, and survival
Management information
Registered date
| 2021 | Year | 06 | Month | 04 | Day |
Last modified on
| 2021 | Year | 06 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050755
