UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038701 |
|---|---|
| Receipt number | R000042426 |
| Scientific Title | Multicenter retrospective study to examine the efficacy of intervention by healthcare providers for hand-foot skin reaction that occurred after sorafenib use for patients with advanced hepatocellular carcinoma |
| Date of disclosure of the study information | 2019/11/27 |
| Last modified on | 2023/02/27 18:05:36 |
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Basic information
Public title
Multicenter retrospective study to examine the efficacy of intervention by healthcare providers for hand-foot skin reaction that occurred after sorafenib use for patients with advanced hepatocellular carcinoma
Acronym
Multicenter retrospective study to examine the efficacy of intervention by healthcare providers for hand-foot skin reaction that occurred after sorafenib use for patients with advanced hepatocellular carcinoma
Scientific Title
Multicenter retrospective study to examine the efficacy of intervention by healthcare providers for hand-foot skin reaction that occurred after sorafenib use for patients with advanced hepatocellular carcinoma
Scientific Title:Acronym
Multicenter retrospective study to examine the efficacy of intervention by healthcare providers for hand-foot skin reaction that occurred after sorafenib use for patients with advanced hepatocellular carcinoma
Region
| Japan |
Condition
Condition
advanced hepatocellular carcinoma
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between the onsets of multikinase inhibitor associated hand-foot skin reaction and prognosis under intervention by helthcare providers after the introduction of sorafenib
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
overall survival
Key secondary outcomes
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Indication criteria for sorafenib included
the following: (1) Child-Pugh grade, A or B; (2) Eastern Cooperative Oncology Group Performance Status, 0 or 1; (3) hemoglobin level, not less than 8.5 g per dL; (4) neutrophil count, more than 1500 per microliter; (5) platelet count, more than 75000 per microliter; (6) total bilirubin level, less than 2.0 mg per dL; (7) alanine and aminotransferases, less than 5-fold the upper limit of the normal range; and (8) no necessity for dialysis.
Key exclusion criteria
Exclusion criteria included the following: (1) A history of serious hypersensitivity to the components of this drug; (2) pregnant women or those who may be pregnant; (3) a history of thrombosis or ischemic heart disease; and (4) brain metastasis.
Target sample size
130
Research contact person
Name of lead principal investigator
| 1st name | Toshiro |
| Middle name | |
| Last name | Kamoshida |
Organization
Hitachi General Hospital
Division name
Department of Gastroenterology
Zip code
317-0077
Address
2-1-1, Jonan-cho, Hitachi City, Ibaragi Prefecture
TEL
0294231111
toshiro.kamoshida.fu@hitachi.com
Public contact
Name of contact person
| 1st name | Toshiro |
| Middle name | |
| Last name | Kamoshida |
Organization
Hitachi General Hospital
Division name
Department of Gastroenterology
Zip code
317-0077
Address
2-1-1, Jonan-cho, Hitachi City, Ibaragi Prefecture
TEL
0294231111
Homepage URL
toshiro.kamoshida.fu@hitachi.com
Sponsor or person
Institute
Hitachi General Hospital
Institute
Department
Personal name
Funding Source
Organization
Hitachi General Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Medical University Ibaraki Medical Center, Ibaraki Prefectual Central Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hitachi General Hospital
Address
2-1-1, Jonan-cho, Hitachi City, Ibaragi Prefecture
Tel
0294231111
toshiro.kamoshida.fu@hitachi.com
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
| 2019 | Year | 11 | Month | 27 | 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
130
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
Completed
Date of protocol fixation
| 2019 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 03 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
(1) Approval by the Ethics Review Board
The principal investigator will submit the protocol of this study to the Ethics Review Board of this institution for inspection, and obtain approval on the study execution from the director of this institution.
(2) Study type/design
A single-center, retrospective, comparative study.
(3) Study period
One year.
(4) Storage of samples from human bodies and information to be used for research
The information obtained in this study will be centrally stored on a security-assured personal computer.
The data will be anonymized, and used for this study alone. As a rule, the principal investigator of this institution must store the data on a password-locked personal computer and paper materials in a key-locked locker in this institution.
As a rule, the data input to a personal computer should be stored for 5 years or 3 years after the publication of an article (the longer period should be chosen).
Management information
Registered date
| 2019 | Year | 11 | Month | 27 | Day |
Last modified on
| 2023 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042426
