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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013415
Receipt No. R000015639
Scientific Title Pharmacokinetic analysis of carboplatin in postoperative patients with Stage I seminoma
Date of disclosure of the study information 2014/03/24
Last modified on 2020/03/21

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Basic information
Public title Pharmacokinetic analysis of carboplatin in postoperative patients with Stage I seminoma
Acronym Pharmacokinetic analysis of carboplatin in postoperative patients with Stage I seminoma
Scientific Title Pharmacokinetic analysis of carboplatin in postoperative patients with Stage I seminoma
Scientific Title:Acronym Pharmacokinetic analysis of carboplatin in postoperative patients with Stage I seminoma
Region
Japan

Condition
Condition postoperative patients with Stage I seminoma
Classification by specialty
Nephrology Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To validate the Calvert formula in postoperative Japanese patients with Stage I seminoma.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Pharmacokinetics analysis
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Blood samples (10 points for 24hours) are collected after the administration of carboplatin for pharmacokinetic analysis.
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
Key inclusion criteria 1) Histologically proven Stage I seminoma patients after sugery
2) Age>=20years
3) Planned to receive carboplatin
4) eGFR>60mL/min
5) ECOG PS:0-1
6)Adequate organ function
white-cell count>= 3,000/uL
platelet count>= 100,000/uL
hemoglobin concentration >= 9.0g/uL
7)Written informed consent
8)Life expectancy more than 3 months
Key exclusion criteria 1) Administration of carboplatin is contraindicated
2) Administration of inulin is contraindicated
3)Judged by investigator to be inappropriate for study participation for serious psychiatric condition
4)Judged by investigator to be inappropriate for study participation for any reason
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Yuichi
Middle name
Last name Ando
Organization Nagoya University Hospital
Division name Clinical Oncology and Chemotherapy
Zip code 466-8560
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-1903
Email yando@med.nagoya-u.ac.jp

Public contact
Name of contact person
1st name Tomoya
Middle name
Last name Shimokata
Organization Nagoya University Hospital
Division name Clinical Oncology and Chemotherapy
Zip code 466-8560
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-1903
Homepage URL
Email tshimo@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Hospital
Institute
Department

Funding Source
Organization None
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 Nagoya University Certified Review Board
Address 65Tsurumai,Showa,Nagoya
Tel 052-744-1901
Email ethics@med.nagoya-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

Other administrative information
Date of disclosure of the study information
2014 Year 03 Month 24 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
2013 Year 12 Month 10 Day
Date of IRB
2014 Year 03 Month 24 Day
Anticipated trial start date
2014 Year 03 Month 24 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 13 Day
Last modified on
2020 Year 03 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015639

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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