UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057135 |
|---|---|
| Receipt number | R000064485 |
| Scientific Title | A prospective cohort study on the analysis of REV7 in pancreatic cancer using EUS-TA specimens and investigating the association between REV7 expression intensity and prognosis |
| Date of disclosure of the study information | 2025/03/01 |
| Last modified on | 2025/10/08 11:06:08 |
* 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
A prospective cohort study on the analysis of REV7 in pancreatic cancer using EUS-TA specimens and investigating the association between REV7 expression intensity and prognosis
Acronym
REV7 in pancreatic cancer analysis and prognosis study
Scientific Title
A prospective cohort study on the analysis of REV7 in pancreatic cancer using EUS-TA specimens and investigating the association between REV7 expression intensity and prognosis
Scientific Title:Acronym
REV7 in pancreatic cancer analysis and prognosis study
Region
| Japan |
Condition
Condition
Advanced pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between the expression intensity of REV7 using the pathological specimens collected by endoscopic ultrasound-guided tissue acquisition (EUS-TA) and prognosis in patients with pancreatic cancer in a prospective cohort study.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the expression intensity of REV7
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. 18 years of age or older
2. Cases diagnosed as unresectable pancreatic cancer by EUS-TA
3. Cases with a pathological diagnosis of adenocarcinoma or adenosquamous carcinoma
Key exclusion criteria
1. Cases that refused to be the subject of this study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kosuke |
| Middle name | |
| Last name | Okuwaki |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa, Japan
TEL
+81-42-778-8111
kokuwaki@kitasato-u.ac.jp
Public contact
Name of contact person
| 1st name | Kosuke |
| Middle name | |
| Last name | Okuwaki |
Organization
Kitasato University School of Medicine
Division name
Department of Gastroenterology
Zip code
252-0374
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa, Japan
TEL
+81-42-778-8111
Homepage URL
kokuwaki@kitasato-u.ac.jp
Sponsor or person
Institute
Kitasato University School of Medicine
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
Institutional Ethics Committee of Kitasato University Hospital
Address
1-15-1 Kitasato Minami Sagamihara Kanagawa, Japan
Tel
+81-42-778-7756
rinrib@med.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
北里大学病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 01 | 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
| 2025 | Year | 02 | Month | 10 | Day |
Date of IRB
| 2025 | Year | 02 | Month | 25 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective cohort study
Management information
Registered date
| 2025 | Year | 02 | Month | 26 | Day |
Last modified on
| 2025 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064485
