UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030757 |
|---|---|
| Receipt number | R000035123 |
| Scientific Title | Comprehensive gene analysis for the specimen of pancreatic cancer obtained by EUS-FNA |
| Date of disclosure of the study information | 2018/01/20 |
| Last modified on | 2024/01/15 14:04:39 |
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Basic information
Public title
Comprehensive gene analysis for the specimen of pancreatic cancer obtained by EUS-FNA
Acronym
Comprehensive gene analysis for the specimen of pancreatic cancer
Scientific Title
Comprehensive gene analysis for the specimen of pancreatic cancer obtained by EUS-FNA
Scientific Title:Acronym
Comprehensive gene analysis for the specimen 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 the acquision rate of the specimen of pancreatic cancer obtained by EUS-FNA for comprehensive gene analysis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acquision rate of the specimen obtained by EUS-FNA for comprehensive gene analysis.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
The specimen of pancreatic cancer obtained by EUS-FNA of the first pass is used for this study.
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. More than 20 years old
2. Hypovascular pancreatic tumor
3. Necessary of EUS-FNA for diagnosis
4. Performance status with more than 2
5. Without severe complication
6. Acquisition of patients agreement
Key exclusion criteria
1. Presence of interveneous vesseles in the puncture line during EUS-FNA
2. High risk of bleeding
3. Difficulty of performing EUS
4. Without informed consent
5. Deemed ineligible
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Mamoru |
| Middle name | |
| Last name | Takenaka |
Organization
Kindai University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
589-8511
Address
377-2, Ohno-Higashi, Osaka-Sayama, Osaka, Japan
TEL
072-366-0221
mamoxyo45@gmail.com
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Kamata |
Organization
Kindai University Faculty of Medicine
Division name
Department of Gastroenterology and Hepatology
Zip code
589-8511
Address
377-2, Ohno-Higashi, Osaka-Sayama, Osaka, Japan
TEL
072-366-0221
Homepage URL
ky11@leto.eonet.ne.jp
Sponsor or person
Institute
Kindai University
Institute
Department
Personal name
Funding Source
Organization
Kindai University
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
Kindai Univercity faculty of medicine
Address
Osaka
Tel
0722201181
ky11@leto.eonet.ne.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
| 2018 | Year | 01 | Month | 20 | Day |
Related information
URL releasing protocol
N/A
Publication of results
Published
Result
URL related to results and publications
N/A
Number of participants that the trial has enrolled
50
Results
The collection rate of EUS-FNB specimens suitable for comprehensive cancer panels using deep sequencing was 93.6%. Mutation in p53 and Smad4 were positively and negatively associated, respectively, with disease control at the initial evaluation. The median time to progression in 15 patients with p53 and without Smad4 mutations was 182.0 days; whereas, it was 92.5 days in other 10 patients; this difference was significant (p = 0.020).
Results date posted
| 2024 | Year | 01 | Month | 15 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Fifty patients with suspected pancreatic cancer presenting consecutively at the Kindai University Hospital between January 2018 and January 2019 were enrolled.
Participant flow
Cancerous tissues from EUS-FNB were obtained from each tumor and subjected to histological examination and mutational analysis.
Adverse events
No adverse events
Outcome measures
The primary endpoint was the collection rate of EUS-FNB specimens suitable for comprehensive cancer panels using deep sequencing. Clinical history and genetic variations between the disease control and progressive disease groups of patients on chemotherapy were evaluated as secondary endpoints.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 01 | Month | 10 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 10 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035123
