UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052201 |
|---|---|
| Receipt number | R000059559 |
| Scientific Title | Investigation of Blood Pressure Variability and Analysis of Risk Factors for Hypertension Using Ambulatory Blood Pressure Monitoring in Patients Receiving Angiogenesis Inhibitors |
| Date of disclosure of the study information | 2023/09/15 |
| Last modified on | 2023/09/12 19:08:53 |
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Basic information
Public title
Investigation of Blood Pressure Variability and Analysis of Risk Factors for Hypertension Using Ambulatory Blood Pressure Monitoring in Patients Receiving Angiogenesis Inhibitors
Acronym
BLOSSOM study
Scientific Title
Investigation of Blood Pressure Variability and Analysis of Risk Factors for Hypertension Using Ambulatory Blood Pressure Monitoring in Patients Receiving Angiogenesis Inhibitors
Scientific Title:Acronym
BLOSSOM study
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Identifying Blood Pressure Variability and Risk Factors for Hypertension in Patients Receiving Angiogenesis Inhibitors
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Changes in blood pressure trends with 24-hour free blood pressure measurement
Key secondary outcomes
Major adverse cardiovascular events (ventricular/supraventricular arrhythmia, heart failure, heart block, sudden cardiac death, other cardiovascular events)
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
Patients 20 years of age or older who are scheduled to receive chemotherapy including one of the following angiogenesis inhibitors (bevacizumab, ramucirumab, aflibercept beta, regorafenib, lenvatinib, sunitinib, sorafenib, or vandetanib)
Key exclusion criteria
1)Patients with a history of prior administration of angiogenesis inhibitors
2)Patients who cannot have 24-hour free blood pressure monitoring
3)Patients with performance status is more than 3
4)Patients on dialysis therapy
5)Patients deemed inappropriate for the study by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | shinya |
| Middle name | |
| Last name | suzuki |
Organization
National cancer center hospital east
Division name
Department of Pharmacy
Zip code
2778577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba
TEL
08034456321
akawanob@gmail.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Kawanobe |
Organization
National cancer center hospital east
Division name
Department of Pharmacy
Zip code
2778577
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba
TEL
0471331111
Homepage URL
akawanob@east.ncc.go.jp
Sponsor or person
Institute
National cancer center hospital east
Institute
Department
Personal name
Funding Source
Organization
National cancer center hospital east
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National cancer center hospital east
Address
6-5-1 Kashiwanoha, Kashiwa-shi Chiba
Tel
0471331111
akawanob@east.ncc.go.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
| 2023 | Year | 09 | Month | 15 | 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
| 2023 | Year | 05 | Month | 30 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 07 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 14 | Day |
Last follow-up date
| 2035 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
If the subject is an inpatient, blood pressure is measured before the start of the first cycle of treatment, on day 1, day 3, and day 8, and once between day 15 and day 29, for a total of five 24-hour free-acting blood pressure measurements. In the case of outpatients, a total of four 24-hour free-acting blood pressure measurements will be taken before the start of the first cycle of treatment, day 1, day 8, and before the start of the second cycle, and the device will be returned to the reception of the Cardiology Outpatient Clinic. The blood pressure is automatically measured every 30 minutes from 8:00 am to 8:00 pm and every 60 minutes from 8:01 pm to 7:59 am. In order to link the medical records and the data obtained from the 24-hour free-action blood pressure measurement, the data are linked using a correspondence table and analyzed. The linked medical records will be used to investigate patient information such as patient background, treatment details, adverse events, and concomitant medications.
Management information
Registered date
| 2023 | Year | 09 | Month | 13 | Day |
Last modified on
| 2023 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059559
