UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042130 |
|---|---|
| Receipt number | R000047463 |
| Scientific Title | Investigation of mechanism of acquired chemoresistance for pancreatic cancer |
| Date of disclosure of the study information | 2020/10/15 |
| Last modified on | 2020/10/15 17:39:49 |
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Basic information
Public title
Investigation of mechanism of acquired chemoresistance for pancreatic cancer
Acronym
acquired chemoresistance in pancreatic cancer
Scientific Title
Investigation of mechanism of acquired chemoresistance for pancreatic cancer
Scientific Title:Acronym
acquired chemoresistance in pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To elucidate the specific acquired resistance mechanism in pancreatic cancer by comprehensively performing genomic analysis, epigenome analysis, and expression analysis using clinical samples. At the same time, we will establish the usefulness of liquid biopsy in pancreatic cancer and establish a high-accuracy sequence analysis method from minute samples.
Basic objectives2
Others
Basic objectives -Others
Elucidation of therapeutic targets in pancreatic cancer chemotherapy
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Identification of acquired chemoresistant mutations in chemotherapy
Key secondary outcomes
Positive rate of liquid biopsy in pancreatic cancer
Success rate of high-precision sequence analysis from minute samples
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) The age at the time of registration is 20 years or older.
2) Invasive pancreatic duct cancer is diagnosed by pathological diagnosis.
3) Healed or unresectable lesion.
4) Chemotherapy is planned.
5) Provide a tumor (any one of 1 and 2) and a non-tumor tissue sample (1 and 3) that can be genetically analyzed.
Tumor tissue
1 Residual sample after treatment
2 Tumor tissue sample newly collected for this study
Non-tumor tissue
1 Residual sample after treatment
3 Peripheral blood sample newly collected for this study (10 mL)
6) Informed consent was obtained from the patient regarding participation in this study.
7) No concurrent double cancer (in case of metachronous double cancer, 5 years or more without recurrence after radical treatment).
8) Comprehensive informed consent has been obtained.
Key exclusion criteria
N/A
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Uwagawa |
Organization
The Jikei University School of Medicine Hospital
Division name
Surgery
Zip code
105-8461
Address
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
uwatadashi@msn.com
Public contact
Name of contact person
| 1st name | Tadashi |
| Middle name | |
| Last name | Uwagawa |
Organization
The Jikei University School of Medicine
Division name
Surgery
Zip code
105-8461
Address
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
TEL
03-3433-1111
Homepage URL
uwatadashi@msn.com
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
National Cancer Center Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University School of Medicine
Address
3-25-8 Nishi-shinbashi, Minato-ku, Tokyo
Tel
03-3433-1111
rinri@jikei.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
| 2020 | Year | 10 | Month | 15 | 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
| 2020 | Year | 06 | Month | 08 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 06 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2020 | Year | 10 | Month | 15 | Day |
Last modified on
| 2020 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047463
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
