UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028487
Receipt No. 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 2017/08/02

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Last name of lead principal investigator
1st name
Middle name
Last name Kenya Kamimura
Organization Niigata University
Division name Division of Gastroenterology and Hepatology
Zip code
Address 1-757, Asahimachido-ri, Chuo-ku, Niigata
TEL 0252272207
Email ethics@adm.niigata-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name same as above
Organization same as above
Division name same as above
Zip code
Address same as above
TEL 0252272207
Homepage URL
Email ethics@adm.niigata-u.ac.jp

Sponsor
Institute Division of Gastroenterology and Hepatology, Graduate School of Medical and Dental Sciences, Niigata University
Institute
Department

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
Address
Tel
Email

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 Enrolling by invitation
Date of protocol fixation
2012 Year 12 Month 18 Day
Date of IRB
Anticipated trial start date
2012 Year 12 Month 18 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information N/A

Management information
Registered date
2017 Year 08 Month 02 Day
Last modified on
2017 Year 08 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032421

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.