UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050100 |
|---|---|
| Receipt number | R000057075 |
| Scientific Title | Exploratory study to elucidate the significance of biomarker measurement by liquid biopsy over time in patients with hepatobiliary and pancreatic malignancies during systemic therapy |
| Date of disclosure of the study information | 2023/01/24 |
| Last modified on | 2023/01/22 02:44:37 |
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Basic information
Public title
Exploratory study to elucidate the significance of biomarker measurement by liquid biopsy over time in patients with hepatobiliary and pancreatic malignancies during systemic therapy
Acronym
Liquid biopsy study during systemic therapy for hepatobiliary pancreatic cancer
Scientific Title
Exploratory study to elucidate the significance of biomarker measurement by liquid biopsy over time in patients with hepatobiliary and pancreatic malignancies during systemic therapy
Scientific Title:Acronym
Liquid biopsy study during systemic therapy for hepatobiliary pancreatic cancer
Region
| Japan |
Condition
Condition
Hepato-biliary pancreatic malignant tumor
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The aim of this study is to investigate the relationship between the trends over time of biomarkers obtained by liquid biopsy and treatment outcomes (efficacy and safety) in patients with the hepatobiliary and pancreatic malignancies during systemic therapy, and to identify biomarkers that are useful in the selection of systemic therapy. The primary endpoint is to examine the relationship between blood ctDNA profile over time and anti-tumor response. The secondary endpoint is to examine the relationship between the treatment outcome and CTCs, miRNAs, tumor markers, cancer immune-related factors, and intestinal microbiota obtained from liquid biopsies (blood, urine, saliva, and stool samples).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between blood ctDNA profile over time and anti-tumor response
Key secondary outcomes
The relationship between the treatment outcome and CTCs, miRNAs, tumor markers, cancer immune-related factors, and intestinal microbiota obtained from liquid biopsies (blood, urine, saliva, and stool samples) other than ctDNA.
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 hepatobiliary and pancreatic malignancies who will receive systemic therapy at Fujita Health University Hospital
2. Patients with a histological or clinical (imaging and tumor markers) diagnosis of hepatobiliary and pancreatic malignancies
3. Patients unsuitable for surgical resection or local therapy
4. Patients with ECOG Performance Status (PS) of 0,1,2
5. Patients over 20 years old
6. Patients with preserved major organ function
7. Patients in which the patient's consent to participate in this study has been obtained
Key exclusion criteria
1. Patients with serious complications
2. Patients who are judged by the investigator to be ineligible for the safe conduct of this study
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Yoshiki |
| Middle name | |
| Last name | Hirooka |
Organization
Fujita Health University
Division name
Department of Gastroenterology and Hepatology
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
TEL
+81562932324
yoshiki.hirooka@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Teiji |
| Middle name | |
| Last name | Kuzuya |
Organization
Fujita Health University
Division name
Department of Gastroenterology and Hepatology
Zip code
470-1192
Address
1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
TEL
+81562932324
Homepage URL
teiji.kuzuya@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University hospital
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
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
Fujita Health University
Address
1-98, Dengakugakubo, Kutsukake-Cho, Toyoake, Aichi
Tel
+81562932865
f-irb@fujita-hu.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 | 01 | Month | 24 | 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
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 11 | Month | 18 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 12 | 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
| 2023 | Year | 01 | Month | 22 | Day |
Last modified on
| 2023 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057075
