UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062085 |
|---|---|
| Receipt number | R000070926 |
| Scientific Title | A Prospective Non-Interventional Observational Study Investigating the Predictive Value of Liquid Biopsy for Treatment Response and Prognosis in Patients with Pancreatic Cancer Undergoing Neoadjuvant Therapy |
| Date of disclosure of the study information | 2026/06/28 |
| Last modified on | 2026/06/28 15:33:04 |
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Basic information
Public title
Liquid Biopsy for Predicting Treatment Response and Prognosis in Pancreatic Cancer Patients Receiving Preoperative Therapy
Acronym
LB-PDAC
Scientific Title
A Prospective Non-Interventional Observational Study Investigating the Predictive Value of Liquid Biopsy for Treatment Response and Prognosis in Patients with Pancreatic Cancer Undergoing Neoadjuvant Therapy
Scientific Title:Acronym
PRELUDE-PDAC Study
Region
| Japan |
Condition
Condition
Pancreatic cancer
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To evaluate whether KRAS gene mutations detected by liquid biopsy can predict the response to neoadjuvant therapy in patients with pancreatic cancer undergoing surgical resection. In addition, this study aims to investigate whether longitudinal monitoring of KRAS mutations can serve as a biomarker for postoperative recurrence and prognosis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Response to neoadjuvant therapy.
Key secondary outcomes
Recurrence-free survival (RFS)
Overall survival (OS)
Efficacy of postoperative adjuvant chemotherapy
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants must meet all of the following criteria:
Clinically diagnosed with pancreatic cancer.
Scheduled to undergo surgical resection.
Aged 20 years or older and younger than 85 years at the time of registration.
Adequate major organ function confirmed by examinations performed within 2 weeks prior to registration.
Key exclusion criteria
Presence of severe comorbidities, including interstitial pneumonia or pulmonary fibrosis, renal failure, hepatic failure, uncontrolled diabetes mellitus, or uncontrolled hypertension.
Presence of active multiple primary cancer(s).
Presence of active multiple primary cancer(s) with a disease-free interval of less than 5 years.
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Keiichi |
| Middle name | |
| Last name | Okano |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Gastroenterological Surgery
Zip code
7610793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
TEL
087-891-2438
okano.keiichi@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Takuro |
| Middle name | |
| Last name | Fuke |
Organization
Faculty of Medicine, Kagawa University
Division name
Department of Gastroenterological Surgery
Zip code
7610793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
TEL
087-891-2438
Homepage URL
fuke.takuro@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee of Kagawa University Faculty of Medicine
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa 761-0793, Japan
Tel
087-891-2011
mdkenkyo7-m@kagawa-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 | 28 | 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
| 2020 | Year | 05 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 05 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 22 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2026 | Year | 06 | Month | 28 | Day |
Last modified on
| 2026 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070926
