UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028487 |
|---|---|
| Receipt number | R000032421 |
| Scientific Title | The usefulness of serum APM2 as a predictable marker for the response to platinum based antineoplastic drugs. |
| Date of disclosure of the study information | 2017/08/02 |
| Last modified on | 2023/02/06 10:51:45 |
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Basic information
Public title
The usefulness of serum APM2 as a predictable marker for the response to platinum based antineoplastic drugs.
Acronym
Serum APM2 as a predictable marker for platinum antineoplastic drug effects
Scientific Title
The usefulness of serum APM2 as a predictable marker for the response to platinum based antineoplastic drugs.
Scientific Title:Acronym
Serum APM2 as a predictable marker for platinum antineoplastic drug effects
Region
| Japan |
Condition
Condition
Hepatocellular carcinoma, Gastric cancer, Esophageal cancer
Classification by specialty
| Gastroenterology | Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of a serum APM2 for determining the effect of platinum antineoplastic drugs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum APM2 concentration
The effect of platinum antineoplastic drugs on the tumors.
Key secondary outcomes
Serum APM2 concentration
The side-effects of platinum antineoplastic drugs on the tumors.
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
(1) Patients diagnosed with malignant tumors and planned to be treated by chemotherapy.
(2) Patients equal or over 20 years old.
Key exclusion criteria
Patients who are considered to be inappropriate candidate for this study by the investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kenya |
| Middle name | |
| Last name | Kamimura |
Organization
Niigata University
Division name
Division of Gastroenterology and Hepatology
Zip code
9518510
Address
1-757, Asahimachido-ri, Chuo-ku, Niigata
TEL
0252272207
ethics@adm.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenya |
| Middle name | |
| Last name | Kamimura |
Organization
same as above
Division name
same as above
Zip code
9518510
Address
same as above
TEL
0252272207
Homepage URL
ethics@adm.niigata-u.ac.jp
Sponsor or person
Institute
Division of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University
Institute
Department
Personal name
Funding Source
Organization
same as above
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
JAPAN
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board
Address
1-754, Asahimachi d-ri, Niigata, Niigata
Tel
025-227-2625,0912
ethics@adm.niigata-u.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
新潟大学医歯学総合病院（新潟県）
Niigata University Medical and Dental Hospital
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 02 | 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
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
| 2012 | Year | 12 | Month | 18 | Day |
Date of IRB
| 2012 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2012 | Year | 12 | Month | 18 | Day |
Last follow-up date
| 2022 | Year | 08 | Month | 05 | Day |
Date of closure to data entry
| 2022 | Year | 08 | Month | 05 | Day |
Date trial data considered complete
| 2022 | Year | 08 | Month | 05 | Day |
Date analysis concluded
| 2022 | Year | 08 | Month | 05 | Day |
Other
Other related information
N/A
Management information
Registered date
| 2017 | Year | 08 | Month | 02 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032421
