UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052237 |
|---|---|
| Receipt number | R000059594 |
| Scientific Title | Evaluation the clinical utility of KRAS mutation assay using tumor samples (tissue, cytology) and blood samples in patients with pancreatic cancer. |
| Date of disclosure of the study information | 2023/09/19 |
| Last modified on | 2023/09/18 23:41:57 |
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Basic information
Public title
Evaluation the clinical utility of KRAS mutation assay using tumor samples (tissue, cytology) and blood samples in patients with pancreatic cancer.
Acronym
Evaluation the clinical utility of KRAS mutation assay using tumor samples (tissue, cytology) and blood samples in patients with pancreatic cancer.
Scientific Title
Evaluation the clinical utility of KRAS mutation assay using tumor samples (tissue, cytology) and blood samples in patients with pancreatic cancer.
Scientific Title:Acronym
Evaluation the clinical utility of KRAS mutation assay using tumor samples (tissue, cytology) and blood samples in patients with 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 clinical performance of KRAS mutation assay by dPCR using tumor (tissue and cytology) and blood specimens in pancreatic cancer patients. In addition, we will evaluate the concordance rate of KRAS mutations in tissue-blood and tissue-cytology specimens.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Success rate of KRAS mutation assay, including tumor samples of tissue and cytology and blood samples
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
| Gene |
Interventions/Control_1
Patients with clinically suspected pancreatic cancer who are scheduled to undergo EUS-FNA/B regardless of the planned treatment for the pancreas will be enrolled. The collected tissue and cytology specimens will be evaluated for KRAS mutations by Next Generation DNA Sequencer (NGS) or digitalPCR(dPCR). The biopsies for pancreatic adenocarcinoma are also evaluated for KRAS mutations. Patients with pancreatic cancer whose tumor specimens are collected by biopsy or surgery will be enrolled, and additional blood samples will be collected at the time of routine blood sampling. Tissue and blood samples will be evaluated for KRAS mutations by NGS or dPCR.
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. Patients with clinically suspected pancreatic adenocarcinoma and scheduled for EUS FNA or EUS FNB, or, patients with pathologically confirmed pancreatic adenocarcinoma and tumor specimen is available.
2. Patients who are at least 18 years of age at the time of consent.
Key exclusion criteria
1. Patients whose participation in this study is decided inappropriate by the principal investigator or subinvestigator.
2. Patients who are strongly suspected to have a specific type of pancreatic cancer based on tumor markers (e.g., IPMC (intraductal papillary mucinous carcinoma), NEN (neuroendocrine neoplasm)).
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Sunakawa |
Organization
St.Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa 216-8511, Japan
TEL
+81-44-977-8111
kumemoto@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Kumiko |
| Middle name | |
| Last name | Umemoto |
Organization
St.Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
2168511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
TEL
+81-44-977-8111
Homepage URL
kumemoto@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
St.Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
DNA Chip Research Inc. and Quantdetect, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa, Japan
Tel
+81-44-977-8111
k-sienbu.mail@marianna-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
| 2023 | Year | 09 | Month | 19 | 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
| 2022 | Year | 09 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 05 | 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
Management information
Registered date
| 2023 | Year | 09 | Month | 18 | Day |
Last modified on
| 2023 | Year | 09 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059594
