UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045110 |
|---|---|
| Receipt number | R000051533 |
| Scientific Title | Comprehensive glycan analysis of resected specimens analysis of hepatocellular carcinoma |
| Date of disclosure of the study information | 2021/09/01 |
| Last modified on | 2025/03/31 11:47:37 |
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Basic information
Public title
Comprehensive glycan analysis of resected specimens analysis of hepatocellular carcinoma
Acronym
Comprehensive glycan analysis of resected specimens analysis
Scientific Title
Comprehensive glycan analysis of resected specimens analysis of hepatocellular carcinoma
Scientific Title:Acronym
Comprehensive glycan analysis of resected specimens analysis
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Comprehensive quantitative analysis of glycans and immunochemical staining for glycosyltransferases GnT-V and FUT8 will be performed using hepatocellular carcinoma resection specimens to elucidate the relationship between glycan expression in cancer cells and existing clinicopathological grade, histopathological grade, prognosis, recurrence, and drug resistance.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comprehensive quantitative analysis of glycans from tissue resection specimens and blood, immunochemical stainability of GnT-V and FUT8
Key secondary outcomes
clinicopathological grade, histopathological grade, prognosis, recurrence, and drug resistance.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients who have given free written consent to participate in this study or who do not refuse to participate in the study.
Key exclusion criteria
Patients who are deemed inappropriate for registration by the physician in charge.
Target sample size
499
Research contact person
Name of lead principal investigator
| 1st name | Toshiya |
| Middle name | |
| Last name | Kamiyama |
Organization
Hokkaido University
Division name
Gastroenterological Surgery I
Zip code
060-8638
Address
N-15, W-7, Kitaku Sapporo
TEL
0117065927
t-kamiya@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Orimo |
Organization
Hokkaido Univarsity
Division name
Gastroenterological Surgery I
Zip code
060-8638
Address
N-15, W-7, Kitaku Sapporo
TEL
0117065927
Homepage URL
kaorioritatsu@yahoo.co.jp
Sponsor or person
Institute
Hokkaido Univarsity Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Science and Technology Agency
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hokkaido University Hospital Clinical Research and Medical Innovation Center
Address
N-14, W-5, Kitaku Sapporo
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2021 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_view_reg.cgi?recptno=R000051533
Publication of results
Unpublished
Result
URL related to results and publications
https://center6.umin.ac.jp/cgi-bin/icdr/ctr_view_reg.cgi?recptno=R000051533
Number of participants that the trial has enrolled
48
Results
39 glycans from 1325.55 m/z to 3336.24 m/z could be detected, of which 4 were related to portal vein invasion, 2 to differentiation, 3 to size tended to be significantly related, 2 to tumor number, 3 to AFP value and 2 to hepatic vein invasion . The malignant potential may increase as the number of associated glycoconjugates increases. Two glycans (tentatively named G2201 and G2666) were significantly associated with recurrence-free survival in univariate analysis.
Results date posted
| 2024 | Year | 08 | Month | 19 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Most of the previous cancer studies using glycan analysis have used patient serum.
Background: comorbidities, race, etc., and how glycosylation on cancer cells is related to the biological malignancy of cancer cells remains unresolved.
Experiments with hepatocellular carcinoma cell lines have shown that the glycosylation of hepatocellular carcinoma cells is not
The finding that glycans different from those previously reported in patient sera were involved in the invasive potential led us to the conclusion that studies in actual resected cancer cell tissues were necessary.
Participant flow
We performed a comprehensive analysis of frozen specimens of 48 resected cases of hepatocellular carcinoma from 2001 to 2006 by fully automated serum glycan profile analysis
Adverse events
Adverse events　none
Outcome measures
N-glycan profile Pathological histological findings AFP PIVKA-II Survival Recurrence rate
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 08 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 23 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The study cohort will consist of 248 cases of resected hepatocellular carcinoma from 2001 to 2006, and the validation cohort will consist of 251 cases from 2007 to 2011, for a total of 499 cases.
Management information
Registered date
| 2021 | Year | 08 | Month | 10 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051533
