UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051084 |
|---|---|
| Receipt number | R000058256 |
| Scientific Title | Exploration of Biomarkers for AFP-PIVKA-II Double-Negative Cases in Hepatocellular Carcinoma |
| Date of disclosure of the study information | 2023/05/17 |
| Last modified on | 2023/05/17 13:13:37 |
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Basic information
Public title
Exploration of Biomarkers for AFP-PIVKA-II Double-Negative Cases in Hepatocellular Carcinoma
Acronym
Exploration of Biomarkers for AFP-PIVKA-II Double-Negative Cases in Hepatocellular Carcinoma
Scientific Title
Exploration of Biomarkers for AFP-PIVKA-II Double-Negative Cases in Hepatocellular Carcinoma
Scientific Title:Acronym
Exploration of Biomarkers for AFP-PIVKA-II Double-Negative Cases in Hepatocellular Carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Exploration of Novel Biomarkers in Double Negative Hepatocellular Carcinoma (DNHC) Cases, Where Both AFP and PIVKA-II Tumor Markers are Negative.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
This study aims to evaluate the efficacy of GOLM1 (Golgi protein 73; GP73), Replication Protein A 3 (RPA3), Stomatin Like 2 (STOML2), Glipican 3, Midkine (MDK), Dkk-1, Heat shock protein 70 (Hsp70), Osteopontin, Squamous cell carcinoma antigen (SCCA), and CA 125 as potential biomarkers in HCC patients with DNHC. Blood samples were collected at the time of diagnosis or before and after treatment (up to four time points, regardless of treatment modality).
Key secondary outcomes
Utilizing our comprehensive database of first-episode liver cancer, we intend to conduct an assessment of the clinical features and prognosis, including recurrence and survival outcomes, in patients with DNHC in comparison to individuals diagnosed with AFP or PIVKA-II positive HCC. Additionally, we will investigate the disparities in biomarker variability and prognosis between patients with AFP or PIVKA-II positive HCC and those with DNHC. To achieve this, blood samples will be collected prior to and following treatment, as specified in the primary endpoints."
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
Select patients who meet all of the following
Patients whose consent is obtained in writing
1)Male or female, age 20 years or older at the time of obtaining consent.
2)Must be diagnosed with hepatocellular carcinoma by imaging or histological examination.
Patients who opt out
1)Men and women 20 years of age or older at the time of diagnosis.
2)Hepatocellular carcinoma diagnosed by imaging or histological examination.
Key exclusion criteria
Patients whose consent is to be obtained in writing
1) Patients with primary tumors of other organs
2) PIVKA-II false positive patients with elevated PIVKA-II due to taking warfarin or using antibiotics within 1 month, or PIVKA-II false negative patients on vitamin K replacement therapy
Opt-out patients
1) Patients with primary tumors of other organs
2) PIVKA-II false-positive patients with elevated PIVKA-II due to taking warfarin or using antibiotics within a month, or PIVKA-II false-negative patients on vitamin K replacement therapy
3) Patients who have refused to allow the use of data collected from their medical information records.
Target sample size
530
Research contact person
Name of lead principal investigator
| 1st name | TAKAAKI |
| Middle name | |
| Last name | SUGIHARA |
Organization
Tottori University Hospital
Division name
Department of Gastroenterology
Zip code
683-8504
Address
36-1, Nishi-cho, Yonago city, Tottori Prefecture
TEL
0859386527
sugitaka@tottori-u.ac.jp
Public contact
Name of contact person
| 1st name | TAKAAKI |
| Middle name | |
| Last name | SUGIHARA |
Organization
Tottori University Hospital
Division name
Tottori University Hospital
Zip code
683-8504
Address
36-1, Nishi-cho, Yonago city, Tottori Prefecture
TEL
0859-38-6527
Homepage URL
sugitaka@tottori-u.ac.jp
Sponsor or person
Institute
Tottori University
Institute
Department
Personal name
Funding Source
Organization
Tottori Prefecture
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Department of Clinical Research Support, Center for the Promotion of Novel Medical Research, Tottori University Hospital
Address
36-1, Nishi-cho, Yonago city, Tottori Prefecture
Tel
0859-38-6946
crsc@ml.med.tottori-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 | 05 | Month | 17 | 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
| 2023 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2023 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2023 | Year | 01 | Month | 17 | 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
Blood samples were collected at the time of diagnosis or before and after treatment (any treatment) (up to 4 times in total) in HCC patients with DNHC, GOLM1 (Golgi protein 73; GP73), Replication Protein A 3 (RPA3), Stomatin Like 2 (STOML2), Stomatin Like 2 (STOML2), Glipican 3, midkine (MDK), Dkk-1, heat shock protein 70 (Hsp70), osteopontin, squamous cell carcinoma antigen (SCCA), and CA 125 will be tested for efficacy. We will also use our database of first-episode liver cancer to evaluate the clinical characteristics and prognosis (recurrence and survival) of DNHC compared to patients with AFP- or PIVKA-II-positive HCC. Furthermore, we will also analyze the differences in biomarker variability and prognosis between AFP- or PIVKA-II-positive HCC patients and DNHC, for whom blood samples will be obtained before and after treatment, as described in the primary endpoints.
Management information
Registered date
| 2023 | Year | 05 | Month | 17 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058256
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