UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061878 |
|---|---|
| Receipt number | R000070805 |
| Scientific Title | An Exploratory Study Evaluating the Clinical Significance of a Novel ALDH1 Activity-Detecting Probe Using Specimens from Patients with Pancreatic Cancer |
| Date of disclosure of the study information | 2026/06/11 |
| Last modified on | 2026/06/11 17:48:19 |
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Basic information
Public title
An Exploratory Study Evaluating the Clinical Significance of a Novel ALDH1 Activity-Detecting Probe Using Specimens from Patients with Pancreatic Cancer
Acronym
ALDH1 Probe Study for Pancreatic Cancer
Scientific Title
An Exploratory Study Evaluating the Clinical Significance of a Novel ALDH1 Activity-Detecting Probe Using Specimens from Patients with Pancreatic Cancer
Scientific Title:Acronym
ALDH1 Probe Study for Pancreatic Cancer
Region
| Japan |
Condition
Condition
Pancreatic Cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In this study, residual specimens obtained from EUS-FNA performed for diagnostic purposes will be used to detect and quantify ALDH1-positive cells using a novel probe for ALDH1 activity. We will exploratorily evaluate (1) the technical feasibility of this approach, (2) its concordance with established pathological indicators, and (3) its association with clinical outcomes and treatment response.
Basic objectives2
Others
Basic objectives -Others
In this study, we aim to establish a rapid and highly sensitive method for detecting and quantifying ALDH1-positive cancer stem cells (CSCs) in pancreatic cancer tissue using a proprietary ALDH1 activity-detecting probe developed by our group and surplus specimens obtained by EUS-FNA at the time of pancreatic cancer diagnosis. In addition, we will determine the relationship between the resulting CSC-based biomarkers and clinical outcomes and treatment response in order to evaluate their utility for prognostic prediction and assessment of therapeutic efficacy. We will also characterize the molecular biological features of ALDH1-positive CSCs and clarify their association with treatment resistance, recurrence, and metastasis, thereby laying the foundation for new CSC-targeted diagnostic and therapeutic strategies.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the proportion of probe-positive cells
Key secondary outcomes
1. Assessment of the correlation between the proportion of probe-positive cells and clinical and pathological characteristics
2. Assessment of the association between the proportion of probe-positive cells and patient prognosis
3. Molecular characterization of probe-positive cells
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. Patients with suspected pancreatic cancer based on imaging examinations and undergoing EUS-FNA.
2. Patients who provide written informed consent for participation in this study.
3. Patients aged 20 years or older at the time of informed consent.
Key exclusion criteria
atients who are deemed unsuitable for participation in this study at the discretion of the investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Yamashita |
Organization
Kanazawa University
Division name
Department of Gastroenterology, Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences
Zip code
9208641
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
0762652235
taroy62m@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Kouki |
| Middle name | |
| Last name | Nio |
Organization
Kanazawa University
Division name
Department of Gastroenterology, Faculty of Medicine, Institute of Medical, Pharmaceutical and Health
Zip code
9208641
Address
13-1 Takara-machi, Kanazawa, Ishikawa
TEL
0762652235
Homepage URL
nio@m-kanazawa.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
none
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
Medical Ethics Committee of Kanazawa University
Address
13-1 Takara-machi, Kanazawa, Ishikawa
Tel
0762652832
rinri@adm.kanazawa-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
| 2026 | Year | 06 | Month | 11 | 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
| 2026 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Period: From the date of approval to March 31, 2029
Enrollment Period: From the date of approval to March 31, 2028
Observation (Follow-up) Period: One year after completion of enrollment
Analysis Period: From the date of approval to March 31, 2029
Note: Each collaborating institution shall obtain approval from its Institutional Review Board (IRB)/Ethics Committee and authorization from the head of the institution in accordance with its own regulations. The study initiation date at each collaborating institution shall be the date on which permission to conduct the study is granted by that institution.
Management information
Registered date
| 2026 | Year | 06 | Month | 11 | Day |
Last modified on
| 2026 | Year | 06 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070805
