UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060568 |
|---|---|
| Receipt number | R000069278 |
| Scientific Title | Research on the Development of a System for Measuring the Blood Concentration of Bevacizumab Using a Flow Cytometer |
| Date of disclosure of the study information | 2026/04/01 |
| Last modified on | 2026/02/03 17:15:21 |
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Basic information
Public title
Research on the Development of a System for Measuring the Blood Concentration of Bevacizumab Using a Flow Cytometer
Acronym
Establishing a Therapeutic Drug Measurement System for Bevacizumab
Scientific Title
Research on the Development of a System for Measuring the Blood Concentration of Bevacizumab Using a Flow Cytometer
Scientific Title:Acronym
Establishing a Therapeutic Drug Measurement System for Bevacizumab
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to develop a method for measuring serum concentrations of bevacizumab applicable to routine clinical practice using a novel technique based on flow cytometry employing antigen-capture beads and detection antibodies.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Compare serum anti-drug antibody concentrations in Japanese patients administered bevacizumab with serum concentrations in clinical trials (Phase II or Phase III trials). Serum bevacizumab concentration per dose is evaluated against the compliance criteria, defined as the mean+/-2SD of the minimum plasma concentration (Cmin) during repeated dosing at 5 mg/kg, 7.5 mg/kg, and 10 mg/kg, as stated in the Avastin intravenous infusion interview form.
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
To participate in this study, all of the following criteria must be met.
1) Patients with unresectable advanced or recurrent colorectal cancer undergoing repeated administration of bevacizumab at 5-10 mg/kg (body weight) per dose, administered at least three times, in the Department of Gastrointestinal Surgery at our hospital between the date of approval and March 31, 2028.
2) Patients whose background information can be verified in medical records.
3) Patients whose informed consent to participate in the study can be confirmed based on their own volition.
Key exclusion criteria
Participants will be excluded from this study if they meet any of the following criteria:
1) Individuals for whom written consent to participate in the study could not be obtained
2) Individuals for whom a blood draw order was not placed within one month after consent was obtained
3) Patients under 18 years of age
4) Patients of foreign nationality
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | TAKUYA |
| Middle name | |
| Last name | IWAMOTO |
Organization
Mie University Hospital
Division name
Department of Pharmacy
Zip code
514-8507
Address
2-174 Edobashi, Tsu, Mie
TEL
07022470552
taku-iwa@med.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | TAKUYA |
| Middle name | |
| Last name | IWAMOTO |
Organization
Mie University Hospital
Division name
Department of Pharmacy
Zip code
5148507
Address
2-174 Edobashi, Tsu, Mie
TEL
070-2247-0552
Homepage URL
taku-iwa@med.mie-u.ac.jp
Sponsor or person
Institute
Mie University
Institute
Department
Personal name
Funding Source
Organization
Mie University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Mie University Hospital
Address
2-174 Edobashi, Tsu, Mie
Tel
070-2247-0552
taku-iwa@med.mie-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
Mie
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 02 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Blood pressure, weight, P.S.
Complete blood count: White blood cell count, hemoglobin, platelet count
Blood chemistry tests: Total protein, albumin, AST, ALT, serum creatinine, BUN
Urinalysis: Protein
Symptoms and signs
Adverse events
Concomitant medications
Management information
Registered date
| 2026 | Year | 02 | Month | 03 | Day |
Last modified on
| 2026 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069278
