UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049452 |
|---|---|
| Receipt number | R000056276 |
| Scientific Title | Translational research associated with 'An investigator-initiated phase II trial of niraparib for patients with BRCA-mutated unresectable/recurrent biliary tract, pancreatic and other gastrointestinal cancer' |
| Date of disclosure of the study information | 2022/11/07 |
| Last modified on | 2023/05/10 22:38:35 |
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Basic information
Public title
Translational research associated with 'An investigator-initiated phase II trial of niraparib for patients with BRCA-mutated unresectable/recurrent biliary tract, pancreatic and other gastrointestinal cancer'
Acronym
NIR-B TR
Scientific Title
Translational research associated with 'An investigator-initiated phase II trial of niraparib for patients with BRCA-mutated unresectable/recurrent biliary tract, pancreatic and other gastrointestinal cancer'
Scientific Title:Acronym
NIR-B TR
Region
| Japan |
Condition
Condition
biliary tract, pancreatic and other gastrointestinal cancers
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Associated with "An investigator-initiated phase II trial of niraparib for patients with BRCA-mutated unresectable/recurrent
biliary tract, pancreatic and other gastrointestinal cancer (NIR-B trial)", we will analyze the association between molecular biology aberrations and therapeutic efficacy in tumor tissue and circulating tumor DNA prior to and after treatment initiation and progression, and explore biomarkers related to efficacy and resistance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Protein expression analysis
Key secondary outcomes
Cancer-related genetic analysis
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
Patients enrolled in "An investigator-initiated phase II trial of niraparib for patients with BRCA-mutated unresectable/recurrent biliary tract, pancreatic and other gastrointestinal cancer (NIR-B trial)" who provide written informed consent for the study or who have consented to provide tumour specimens for ancillary studies at the time of participating in NIR-B trial.
Key exclusion criteria
None
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Kawamoto |
Organization
Hokkaido University Hospital
Division name
Cancer Center
Zip code
060-8648
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5756
y-kawamoto@pop.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Kawamoto |
Organization
Hokkaido University Hospital
Division name
Cancer Center
Zip code
060-8648
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL
011-706-5756
Homepage URL
y-kawamoto@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Takeda Pharmaceutical Co.,Ltd.
IRB Contact (For public release)
Organization
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita 14, Nishi 5, Kita-Ku, Sapporo, Hokkaido
Tel
011-706-7636
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
| 2022 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 28 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 11 | Month | 07 | Day |
Last modified on
| 2023 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056276
| 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 |
