UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052284 |
|---|---|
| Receipt number | R000059687 |
| Scientific Title | Prognostic impact of angiotensin-converting enzyme inhibitors and angiotensin receptors blockers in cancer patients |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2025/04/09 14:58:19 |
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Basic information
Public title
Prognostic impact of angiotensin-converting enzyme inhibitors and angiotensin receptors blockers in cancer patients
Acronym
Prognostic impact of angiotensin-converting enzyme inhibitors and angiotensin receptors blockers in cancer patients
Scientific Title
Prognostic impact of angiotensin-converting enzyme inhibitors and angiotensin receptors blockers in cancer patients
Scientific Title:Acronym
Prognostic impact of angiotensin-converting enzyme inhibitors and angiotensin receptors blockers in cancer patients
Region
| Japan |
Condition
Condition
Cancer Patients
Classification by specialty
| Medicine in general |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A Systematic Review and Meta-Analysis of ACE Inhibitor/ARB Administration and Prognostic Impact in Cancer Patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is to evaluate ACE inhibitor/ARB treatment in patients being treated for malignancy in relation to reduction in cardiotoxicity, respiratory distress, and improvement in quality of life.
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
Male and Female
Key inclusion criteria
Only papers in English will be incorporated. Other articles (e.g., non-English papers, short reports, conference abstracts, etc.) will be excluded. Include parallel-group, individually randomized controlled trials (RCTs), but not cluster RCTs or crossover RCTs; trials with more than three arms will also be included if they meet the criteria. Include non-inferiority trials as well as superiority trials. RCTs of any phase will be included, but trials that do not report safety data will be excluded.
The main inclusion criteria are.
(1) RCTs including angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptors blockers (ARB) arm and control arm in adult malignancies. Controls were classified as placebo or non-placebo.
(2) For multi-arm studies, at least one arm must include an ACE inhibitor or ARB group.
(3)Trials that demonstrate efficacy results such as cardioprotection, reduction in respiratory distress, or improvement in quality of life.
Key exclusion criteria
(1) Systematic review or meta-analysis articles.
(2) Retrospective analysis.
(3) Single prospective cohort study without a control group.
(4) Non-RCT.
(5) The republished research literature is excluded unless the research includes new findings related to outcomes listed in inclusion criteria.
(6) Studies with no or insufficient safety results at the time of the literature search.
(7) 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
045-787-2635
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
045-787-2635
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
Self funding
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
045-787-2635
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
| 2023 | Year | 10 | 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
| 2023 | Year | 09 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Search for candidate articles using PubMed, Cochrane, EMBASE, and Web of Science Core Collection in September 2023. A hand search will be conducted by two investigators.
RCTs that meet the following criteria will be considered for inclusion.
Participants: Patients with clinically diagnosed any malignancy.
Intervention: Cancer therapy plus ACE inhibitor/ARB.
Comparison: Cancer treatment and control treatment group. Control treatment included placebo and non-placebo treatment.
Outcomes: Endpoints related to reduction in cardiotoxicity, relief of respiratory distress, and improvement in quality of life during the observation period.
Two investigators independently will screen all titles, abstracts, and full texts for eligibility. Final inclusion will be decided after resolving discrepancies between the two investigators.
Risk of bias for each study will be assessed with the Cochrane risk of bias (RoB) tool.
Management information
Registered date
| 2023 | Year | 09 | Month | 22 | Day |
Last modified on
| 2025 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059687
