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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044390
Receipt No. R000048719
Scientific Title Elucidation of the relationship between cancer cachexia progression and CYP3A4 and OATP1B activity
Date of disclosure of the study information 2021/06/01
Last modified on 2021/06/01

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Basic information
Public title Elucidation of the relationship between cancer cachexia progression and CYP3A4 and OATP1B activity
Acronym Elucidation of the relationship between cancer cachexia progression and CYP3A4 and OATP1B activity
Scientific Title Elucidation of the relationship between cancer cachexia progression and CYP3A4 and OATP1B activity
Scientific Title:Acronym Elucidation of the relationship between cancer cachexia progression and CYP3A4 and OATP1B activity
Region
Japan

Condition
Condition Cancer Cachexia
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Elucidate the association of cancer cachexia progression on CYP3A4 and OATP1B activity
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of the effect of cancer cachexia progression on CYP3A4 and OATP1B activity
Key secondary outcomes 1) Relationship between cancer cachexia progression and plasma 4b-OHC concentration, the endogenous substrate for CYP3A4.
2) Relationship between cancer cachexia progression and plasma CP concentration, the endogenous substrate for OATP1B.
3) Relationship between plasma 4b-OHC concentration and inflammatory cytokine concentration.
4) Relationship between plasma CP concentration and inflammatory cytokine concentration.
5) Relationship between Phenotype of CYP3A5 gene polymorphism and plasma 4b-OHC concentration, various inflammatory cytokine concentrations, and cancer cachexia progression.
6) Relationship between Phenotype of OATP1B gene polymorphism and plasma CP concentration, various inflammatory cytokine concentrations, and cancer cachexia progression.


Base
Study type Others,meta-analysis etc

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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Cancer patients can be evaluated for the progression of cachexia.
Key exclusion criteria Patients who are concomitantly using drugs that induce or inhibit CYP3A and OATP1B. Patients with hepatic/renal dysfunction.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Takahiro
Middle name
Last name Sumimoto
Organization Oita University Hospital
Division name Clinical pharmacy
Zip code 8705593
Address 1-1, Idaigaoka, Hasama, Yufu, Oita, Japan
TEL 0975866112
Email sumimoto@oita-u.ac.jp

Public contact
Name of contact person
1st name Takahiro
Middle name
Last name Sumimoto
Organization Oita University Hospital
Division name Clinical pharmacy
Zip code 8705593
Address 1-1, Idaigaoka, Hasama, Yufu, Oita, Japan
TEL 0975866112
Homepage URL
Email sumimoto@oita-u.ac.jp

Sponsor
Institute facluty of medicine, Oita University Hospital
Institute
Department

Funding Source
Organization Department of clinical pharmacy, Oita University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Medication Use Analysis and Clinical Research, Meiji Pharmaceutical University
Name of secondary funder(s)

IRB Contact (For public release)
Organization The ethics committee of Oita University
Address 1-1, Idaigaoka, Hasama, Yufu, Oita, Japan
Tel 0975866380
Email rinrikenkyu@oita-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
2021 Year 06 Month 01 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
2020 Year 05 Month 25 Day
Date of IRB
2020 Year 05 Month 28 Day
Anticipated trial start date
2020 Year 06 Month 01 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design:Case-control study

Management information
Registered date
2021 Year 06 Month 01 Day
Last modified on
2021 Year 06 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048719

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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