UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049847 |
|---|---|
| Receipt number | R000056782 |
| Scientific Title | Questionnaire survey of patients and physicians for Early-stage hepatocellular carcinoma |
| Date of disclosure of the study information | 2022/12/22 |
| Last modified on | 2024/07/18 09:37:38 |
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Basic information
Public title
Questionnaire survey of patients and physicians for Early-stage hepatocellular carcinoma
Acronym
Questionnaire survey of patients and physicians for Early-stage hepatocellular carcinoma
Scientific Title
Questionnaire survey of patients and physicians for Early-stage hepatocellular carcinoma
Scientific Title:Acronym
Questionnaire survey of patients and physicians for Early-stage hepatocellular carcinoma
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine | Hepato-biliary-pancreatic surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the well-being changes and those reasons in patients with hepatocellular carcinoma receiving repeated locoregional therapy (hepatectomy or ablation).
Basic objectives2
Others
Basic objectives -Others
To clarify the important things for patients in locoregional therapy and adjuvant therapy from the views of patients who received locoregional therapy and physicians who performed locoregional therapy, respectively.
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Well-being and the factors associated with well-being changes in patients with Early-stage hepatocellular carcinoma
Key secondary outcomes
To clarify the important things for patients in locoregional therapy and adjuvant therapy from the views of patients who received locoregional therapy and physicians who performed locoregional therapy, respectively.
Base
Study type
Others,meta-analysis etc
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
Patients
1. Aged less than 20years
2.Residents of Japan who received locoregional therapy for hepatocellular carcinoma (hepatectomy or ablation) more than two times
3.Within 5 years of last locoregional therapy (hepatectomy or ablation)
4.Signed informed consent form
Physicians
1.Licensed Japanese medical doctors who performed an average of at least 5cases/year of hepatectomy or ablation within 5 years
2.At least five cases of hepatectomy or ablation in the last year
3.Signed informed consent form
Key exclusion criteria
Patients who are engaged in a pharmaceutical, medical, or survey-related job
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Matsumoto |
Organization
Ono Pharmaceutical Co., Ltd.
Division name
Oncology Medical, Medical Affairs
Zip code
103-0023
Address
9-11, Nihonbashi-Honcho 4-Chome Chuo-ku, Tokyo
TEL
03-5640-3711
hi.matsumoto@ono-pharma.com
Public contact
Name of contact person
| 1st name | Anri |
| Middle name | |
| Last name | Watanabe |
Organization
3H Clinical Trial Co., Ltd.
Division name
Insight & Outcome Group
Zip code
171-0022
Address
1-13-23,Minamiikebukuro,Toshima-ku, Tokyo,JRE Minamiikebukuro Building 2F
TEL
03-5985-0053
Homepage URL
a-watanabe@3h-ct.co.jp
Sponsor or person
Institute
Ono Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ono Pharmaceutical Co., Ltd.
Bristol-Myers Squibb K.K.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Japan Conference of Clinical Research
Address
1-13-23,Minamiikebukuro,Toshima-ku, Tokyo.
Tel
03-6868-7022
jccr-info@jccr.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
| 2022 | Year | 12 | Month | 22 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/39009523/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/39009523/
Number of participants that the trial has enrolled
277
Results
atients showed no significant changes in well-being over time, but those with recurrences and repeated locoregional therapy reported increased anxiety. Both patients and physicians prioritize efficacy and safety for locoregional therapy, but patients emphasize reducing the number of therapies with recurrence. For adjuvant therapy, both prioritize treatment effectiveness and adverse effects, while patients prioritize maintaining a normal daily life and physicians prioritize treatment duration.
Results date posted
| 2024 | Year | 07 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients
1. Aged less than 20years
2.Residents of Japan who received locoregional therapy for hepatocellular carcinoma (hepatectomy or ablation) more than two times
3.Within 5 years of last locoregional therapy (hepatectomy or ablation)
Physicians
1.Licensed Japanese medical doctors who performed an average of at least 5cases/year of hepatectomy or ablation within 5 years
2.At least five cases of hepatectomy or ablation in the last year
Participant flow
This study was an internet-based questionnaire survey conducted from 12 2022 to January 2023. Patient survey was conducted using a questionnaire panel of GMO Research Co., Ltd. and cancer information sites Oncolo and QLife Co., Ltd., and physician survey was conducted using a questionnaire panel of Pramed Co., Ltd.
Adverse events
No record found
Outcome measures
Well-being and the factors associated with well-being changes in patients with Early-stage hepatocellular carcinoma
To clarify the important things for patients in locoregional therapy and adjuvant therapy from the views of patients who received locoregional therapy and physicians who performed locoregional therapy, respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2022 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 16 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 23 | Day |
Last follow-up date
| 2023 | Year | 01 | Month | 16 | Day |
Date of closure to data entry
| 2023 | Year | 01 | Month | 16 | Day |
Date trial data considered complete
| 2023 | Year | 02 | Month | 01 | Day |
Date analysis concluded
| 2023 | Year | 07 | Month | 26 | Day |
Other
Other related information
None
Management information
Registered date
| 2022 | Year | 12 | Month | 21 | Day |
Last modified on
| 2024 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056782
