UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038203 |
|---|---|
| Receipt number | R000043538 |
| Scientific Title | Exploratory study of factors affecting poor response in MSI test using EUS-FNAB sample of pancreatic cancer |
| Date of disclosure of the study information | 2019/10/04 |
| Last modified on | 2022/11/01 11:59:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Exploratory study of factors affecting poor response in MSI test using EUS-FNAB sample of pancreatic cancer
Acronym
Exploratory study of factors affecting poor response in MSI test using EUS-FNAB sample of pancreatic cancer
Scientific Title
Exploratory study of factors affecting poor response in MSI test using EUS-FNAB sample of pancreatic cancer
Scientific Title:Acronym
Exploratory study of factors affecting poor response in MSI test using EUS-FNAB sample of pancreatic cancer
Region
| Japan |
Condition
Condition
pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate factors affecting poor response in MSI test using EUS-FNAB sample of pancreatic cancer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
factors related to poor response in MSI test
Key secondary outcomes
proportion of MSI-High
proportion of MSI test failure
accuracy, sensitivity, specificity, positive predictive value, negative predictive value of EUS-FNAB for malignant diagnosis
tissue sampling rate
adverse events
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. age =>20
2. patients undergoing chemotherapy for pancreatic cancer
Key exclusion criteria
1. patients who have difficulty with chemotherapy
2. patients whose participation in the trial was judged to be inappropriate by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Masafumi |
| Middle name | |
| Last name | Watanabe |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan
TEL
042-778-8111
m.wata@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Masafumi |
| Middle name | |
| Last name | Watanabe |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan
TEL
042-778-8111
Homepage URL
m.wata@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Kitasato University School of Medicine
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
Kitasato University school of medicine, Institutional Review Board
Address
1-15-1, Kitasato, Minami-ku, Sagamihara Kanagawa 252-0374, Japan
Tel
042-778-8111
m.wata@kitasato-u.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
| 2019 | Year | 10 | Month | 04 | Day |
Related information
URL releasing protocol
https://doi.org/10.2958/suizo.37.257
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.2958/suizo.37.257
Number of participants that the trial has enrolled
73
Results
MSI was found in 73 patients,and could be evaluated in 72(98.6%).
No factors significantly affecting
the ability to evaluate MSI could be identified.
Results date posted
| 2022 | Year | 11 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
We prospectively collected MSI evaluation results for patients diagnosed with pancreatic cancer by endoscopic ultrasound guided fine needle aspiration from September 2019 to April 2021.
Participant flow
We prospectively collected MSI evaluation results for patients diagnosed with pancreatic cancer by endoscopic ultrasound guided fine needle aspiration from September 2019 to April 2021.
Adverse events
None
Outcome measures
Factors affecting the ability to evaluate MSI.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 07 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 06 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 05 | Month | 31 | Day |
Other
Other related information
Observation items:
1 Patient characteristics
2 EUS FNAB results
3 Histopathology items
4 Chemotherapy
Management information
Registered date
| 2019 | Year | 10 | Month | 04 | Day |
Last modified on
| 2022 | 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=R000043538
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
