UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054592 |
|---|---|
| Receipt number | R000062382 |
| Scientific Title | Comprehensive Pancreatic Cancer Biomarker Analysis of Fecal and Blood Metabolites and Gut Microbiota |
| Date of disclosure of the study information | 2024/06/06 |
| Last modified on | 2024/06/06 15:22:23 |
* 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
Comprehensive Pancreatic Cancer Biomarker Analysis of Fecal and Blood Metabolites and Gut Microbiota
Acronym
Pancreatic Cancer Biomarker discovery study in Feces and Blood
Scientific Title
Comprehensive Pancreatic Cancer Biomarker Analysis of Fecal and Blood Metabolites and Gut Microbiota
Scientific Title:Acronym
Pancreatic Cancer Biomarker discovery study in Feces and Blood
Region
| Japan |
Condition
Condition
pancreatic cancer patient, Patients without pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To Search for new biomarkers associated with pancreatic cancer.
Basic objectives2
Others
Basic objectives -Others
Efficacy
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
To search for new biomarkers specific to pancreatic cancer, based on the results of comprehensive metabolite and gut microbiota analysis obtained from the samples in this study.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
More than 20 years old and less than 90 years old
Pancreatic cancer group: Patients diagnosed with resectable pancreatic cancer or resectable borderline pancreatic cancer
Control group: Patients without pancreatic cancer
Key exclusion criteria
(1) pancreatic cancer patients previously treated
(2) Patients with severe intestinal diseases
(3) Patients who have undergone bowel cleansing within 3 months
(4) Patients who have received antibiotics or laxatives within 3 months
(5) individuals who did not accept informed consent
(6) Patients who cannot collect the necessary volume of sample for analysis
(7) unsuitable individuals for this clinical study
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Osawa |
Organization
The University of Tokyo
Division name
Research Center for Advanced Science and Technology
Zip code
153-8904
Address
Room 317 Building 4, RCAST, The University of Tokyo, 4-6-1 Komaba, Meguro-ku, Tokyo, 153-8904, JAPAN
TEL
03-5452-5025
osawa@lsbm.org
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Osawa |
Organization
The University of Tokyo
Division name
Research Center for Advanced Science and Technology
Zip code
153-8904
Address
Room 317 Building 4, RCAST, The University of Tokyo, 4-6-1 Komaba, Meguro-ku, Tokyo, 153-8904, JAPAN
TEL
03-5452-5025
Homepage URL
osawa@lsbm.org
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Funding Source
Organization
EIKEN CHEMICAL CO.,LTD.
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kochi Medical School Hospital, Kochi University
Kochi Health Sciences Center
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The University of Tokyo
Address
Room 317 Building 4, RCAST, The University of Tokyo, 4-6-1 Komaba, Meguro-ku, Tokyo, 153-8904, JAPAN
Tel
03-5452-5025
osawa@lsbm.org
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
| 2024 | Year | 06 | Month | 06 | 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
| 2023 | Year | 09 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 06 | Month | 06 | Day |
Last modified on
| 2024 | Year | 06 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062382
