UMIN-ICDS Clinical Trial

Public title

Collection and storage of residual tissue, blood, and clinical information from patients with liver cancer for future research

Acronym

HCC Biobank Study

Scientific Title

Establishment of a biobank and database using residual clinical specimens and clinical information from patients with hepatocellular carcinoma

Scientific Title:Acronym

HCC Biobank

Region

Japan

Condition

Hepatocellular carcinoma

Classification by specialty

Hepato-biliary-pancreatic medicine

Hematology and clinical oncology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

To establish a biobank and database for research on the pathogenesis of liver diseases and for the discovery of diagnostic, prognostic, and predictive biomarkers. The biobank will collect and store residual tissue (tumor and non-tumor) obtained during routine clinical care of patients with hepatocellular carcinoma, peripheral blood collected for research purposes, and associated clinical information. This study is limited to collecting and storing specimens and data; each analytical study using them will be conducted under a separate protocol approved by the ethics committee.

Basic objectives2

Others

Basic objectives -Others

Collection and storage of biospecimens and clinical information from patients with hepatocellular carcinoma (establishment of a biobank and database)

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Achievement rate of the target specimen collection at the end of the enrollment period (December 31, 2030), defined as the proportion of patients with collected specimens relative to the planned 90 patients

Key secondary outcomes

At the end of the enrollment period:
Consent rate (proportion of patients who gave consent among those who received an explanation of the study)
Completeness of clinical data (proportion of planned clinical information items that were obtained)

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who meet all of the following criteria:
Patients diagnosed with hepatocellular carcinoma who undergo treatment (surgery, biopsy, puncture, catheter-based therapy, etc.) at Sapporo Medical University Hospital
Patients aged 20 years or older at the time of consent
Patients who have given written informed consent to participate in this study
Patients from whom residual tissue is obtained during clinical care, or from whom blood can be collected for research purposes

Key exclusion criteria

Patients who meet any of the following criteria:
Patients who do not consent to participate in this study
Patients for whom blood collection or specimen sampling for research is judged difficult by the investigators, for example because of poor general condition
Patients otherwise judged by the investigators to be unsuitable for this study

Target sample size

90

Name of lead principal investigator

1st name	YUTAKA
Middle name
Last name	KAWANO

Organization

Sapporo Medical University School of Medicine

Division name

Division of Medical Oncology, Department of Internal Medicine

Zip code

060-8543

Address

South-1 West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan

TEL

0116112111

Email

ykawano@sapmed.ac.jp

Name of contact person

1st name	YUTAKA
Middle name
Last name	KAWANO

Organization

Sapporo Medical University School of Medicine

Division name

Division of Medical Oncology, Department of Internal Medicine

Zip code

005-0018

Address

South-1 West-16, Chuo-ku, Sapporo, Hokkaido, 060-8543, Japan

TEL

0116112111

Homepage URL

https://web.sapmed.ac.jp/im4/so92kt0000000bv2.html

Email

ykawano@sapmed.ac.jp

Institute

Sapporo Medical University School of Medicine

Institute

Department

Personal name

YUTAKA KAWANO

Organization

Sapporo Medical University School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Institutional Review Board, Sapporo Medical University Hospital

Address

South-1, West -16, Chuo-ku, Sapporo, Hokkaido

Tel

0116112111

Email

irb_info@sapmed.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

札幌医科大学附属病院（北海道）

Date of disclosure of the study information

2026

Year

10

Month

22

Day

URL releasing protocol

Publication of results

Unpublished

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 will not be made publicly available. Data may be provided to other research institutions only under a separate research protocol approved by the ethics committee.

IPD sharing Plan description

De-identified specimens and data collected and stored in this study may be used for future research not specified at the time of consent, or provided to other research institutions. In such cases, a separate research protocol will be prepared for each study and approved by the Clinical Research Review Board (ethics committee) before use. If the intended use exceeds the scope of the original consent, new consent will be obtained, or procedures will follow the ethical guidelines applicable at that time.

Recruitment status

Enrolling by invitation

Date of protocol fixation

2026

Year

08

Month

24

Day

Date of IRB

2026

Year

10

Month

18

Day

Anticipated trial start date

2026

Year

10

Month

22

Day

Last follow-up date

2031

Year

03

Month

31

Day

Date of closure to data entry

2031

Year

03

Month

31

Day

Date trial data considered complete

2031

Year

03

Month

31

Day

Date analysis concluded

2031

Year

03

Month

31

Day

Other related information

[Design] Single-center prospective observational study to establish a biobank and database for collecting and storing specimens and clinical information.
[Recruitment] Patients diagnosed with hepatocellular carcinoma who undergo surgery, biopsy, puncture, catheter-based therapy, or other procedures at Sapporo Medical University Hospital between the date of approval by the hospital director and December 31, 2030, and who provide written informed consent.
[Specimens] Residual tissue (tumor and non-tumor) obtained during clinical care; approximately 10 mL of peripheral blood collected for research purposes (separated into serum, plasma, and peripheral blood mononuclear cells for storage).
[Data] Patient background, physical findings, laboratory data (virological tests, hematology and biochemistry, tumor markers, fibrosis markers, etc.), imaging findings, pathological findings, treatment details, and clinical course and outcomes.
[Study period] From approval by the hospital director to March 31, 2031.

Registered date

2026

Year

10

Month

21

Day

Last modified on

2026

Year

10

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072533