UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060252 |
|---|---|
| Receipt number | R000068403 |
| Scientific Title | A Meta-analysis of the Incidence of Hypertension in Patients with Breast Cancer Treated with Anthracycline-based Chemotherapy |
| Date of disclosure of the study information | 2026/01/05 |
| Last modified on | 2026/01/05 00:11:51 |
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Basic information
Public title
A Meta-analysis of the Incidence of Hypertension in Patients with Breast Cancer Treated with Anthracycline-based Chemotherapy
Acronym
A Meta-analysis of the Incidence of Hypertension in Patients with Breast Cancer Treated with Anthracycline-based Chemotherapy
Scientific Title
A Meta-analysis of the Incidence of Hypertension in Patients with Breast Cancer Treated with Anthracycline-based Chemotherapy
Scientific Title:Acronym
A Meta-analysis of the Incidence of Hypertension in Patients with Breast Cancer Treated with Anthracycline-based Chemotherapy
Region
| Japan |
Condition
Condition
Breast cancer patient
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study aims to enhance survivorship in cancer patients. We will perform a meta-analysis of randomized controlled trials to evaluate the incidence of hypertension in breast cancer patients treated with anthracyclines.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Incidence of Hypertension Associated with Anthracycline Therapy
Key secondary outcomes
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
We will include only English full-articles. The other article including non-English article, short article, and conference abstract will be excluded. We will include parallel-group individual randomized controlled trials (RCTs) but not cluster RCTs, or cross-over RCTs. A trial with three or more arms will be accepted. Along with superiority trials, non-inferiority trials will be allowed. Any phase RCT may be included. Trials not reporting data about safety outcomes will be excluded.
Key inclusion criteria are as follows.
1) Randomized controlled trials involving adult patients with breast cancer receiving anthracycline-based therapy.
2) Multi-arm trials in which at least one treatment arm includes anthracycline-based therapy.
3) Trials reporting outcomes related to the incidence of hypertension.
Key exclusion criteria
1) Non-RCT.
2) The republished research literature is excluded unless the research includes new findings related to adverse events listed in inclusion criteria.
3) Studies with no or insufficient safety results at the time of the literature search.
4) Studies published in languages other than English.
Two investigators independently screened all titles, abstracts, and full texts for eligibility. Final inclusion will be decided after resolving discrepancies between the two investigators.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Shintaro |
| Middle name | |
| Last name | Minegishi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2800
minegishi.shi.fb@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | Shintaro |
| Middle name | |
| Last name | Minegishi |
Organization
Yokohama City University Graduate School of Medicine
Division name
Department of Cardiology
Zip code
236-0004
Address
3-9, Kanazawa, Fukuura, Yokohama
TEL
045-787-2800
Homepage URL
minegishi.shi.fb@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Yokohama City University Graduate School of Medicine
Address
3-9, Kanazawa, Fukuura, Yokohama
Tel
045-787-2800
minegishi.shi.fb@yokohama-cu.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
| 2026 | Year | 01 | Month | 05 | 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
| 2025 | Year | 07 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 01 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We searched for candidate articles using PubMed, Cochrane, EMBASE, and Web of Science Core Collection in July 2025.
RCTs meeting the following criteria will be considered for inclusion:
Participants: Patients diagnosed with breast cancer.
Intervention: Trials including at least one treatment arm containing anthracycline-based therapy. Any dosing regimen of anthracyclines will be eligible.
Comparison: None.
Outcomes: Hypertension of ICI therapy (all grade and grade 3-5) during the observational period will be the primary outcome of our study.
Grading of events were classified according to the Common Terminology Criteria for Adverse Events (CTCAE) system.
Quality assessment:
The risk of bias of each study will be assessed by Cochrane risk of bias (RoB) tool for randomized trials.
Management information
Registered date
| 2026 | Year | 01 | Month | 05 | Day |
Last modified on
| 2026 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068403
