UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039697 |
|---|---|
| Receipt number | R000045275 |
| Scientific Title | Novel Ultrasonographic Scoring System of Sinusoidal Obstruction Syndrome associated with Oxaliplatin-based Chemotherapy in patients with Gastrointestinal Cancer. |
| Date of disclosure of the study information | 2020/03/05 |
| Last modified on | 2023/04/03 00:18:03 |
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Basic information
Public title
Novel Ultrasonographic Scoring System of Sinusoidal Obstruction Syndrome associated with Oxaliplatin-based Chemotherapy in patients with Gastrointestinal Cancer.
Acronym
Novel Ultrasonographic Scoring System of Sinusoidal Obstruction Syndrome associated with Oxaliplatin-based Chemotherapy in patients with Gastrointestinal Cancer.
Scientific Title
Novel Ultrasonographic Scoring System of Sinusoidal Obstruction Syndrome associated with Oxaliplatin-based Chemotherapy in patients with Gastrointestinal Cancer.
Scientific Title:Acronym
Novel Ultrasonographic Scoring System of Sinusoidal Obstruction Syndrome associated with Oxaliplatin-based Chemotherapy in patients with Gastrointestinal Cancer.
Region
| Japan |
Condition
Condition
gastrointestinal cancer treated with oxaliplatin-based chemotherapy
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investigate whether US scoring system called HokUS-10 make it possible to early detect SOS/VOD.
Basic objectives2
Others
Basic objectives -Others
We investigate whether HokUS-10 may make it possible to early detect SOS/VOD before the appearance of the increase in spleen volume known as a diagnostic indicator.
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is a probability that a high score of HokUS-10 and the increases in spleen volume of computed tomography are observed in the same case.
Key secondary outcomes
The secondary endpoint is a probability that a high score of HokUS-10 and the diagnosis of SOS/VOD based on histopathological findings are observed in the same case.
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
The patients with gastrointestinal cancer who are planned to receive scheduled to receive oxaliplatin-based chemotherapy.
Key exclusion criteria
1) Patients who have received Oxaliplatin in past treatment.
2) Patients with cirrhosis or chronic hepatitis.
3) Case after liver resection.
4) Case after splenectomy.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yoshito |
| Middle name | |
| Last name | Komatsu |
Organization
Hokkaido University Hospital
Division name
Division of Cancer Center
Zip code
060-8648
Address
Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido, Japan
TEL
0117161161
ykomatsu@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Rika |
| Middle name | |
| Last name | Saito |
Organization
Hokkaido University Hospital
Division name
Division of Cancer Center
Zip code
060-8648
Address
Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido, Japan
TEL
0117161161
Homepage URL
lica.saitou@med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido university hospital
Institute
Department
Personal name
Funding Source
Organization
Hokkaido university hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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
Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido, Japan
Tel
0117161161
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
| 2020 | Year | 03 | Month | 05 | 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
51
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 | 11 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 11 | Day |
Anticipated trial start date
| 2019 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
HokUS-10 is a scoring system using transabdominal ultrasonography consisting of 10 parameters: hepatomegaly in the (1) left lobe and (2) right lobe, (3) gallbladder wall thickening, (4) portal vein (PV) diameter, (5) paraumbilical vein (PUV) diameter, (6) Amount of ascites, (7) PV mean velocity, (8) Direction of PV flow, (9) Appearance of PUV blood flow signal, (10) hepatic artery resistance-index.
Management information
Registered date
| 2020 | Year | 03 | Month | 04 | Day |
Last modified on
| 2023 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045275
