UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048395 |
|---|---|
| Receipt number | R000055165 |
| Scientific Title | Angiotensin Receptor-Neprilysin Inhibitor (ARNI) and Cancer Risk: A systematic review and network meta-analysis |
| Date of disclosure of the study information | 2022/07/18 |
| Last modified on | 2024/02/02 22:38:46 |
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Basic information
Public title
Angiotensin Receptor-Neprilysin Inhibitor (ARNI) and Cancer Risk: A systematic review and network meta-analysis
Acronym
Angiotensin Receptor-Neprilysin Inhibitor (ARNI) and Cancer Risk: A systematic review and network meta-analysis
Scientific Title
Angiotensin Receptor-Neprilysin Inhibitor (ARNI) and Cancer Risk: A systematic review and network meta-analysis
Scientific Title:Acronym
Angiotensin Receptor-Neprilysin Inhibitor (ARNI) and Cancer Risk: A systematic review and network meta-analysis
Region
| Japan |
Condition
Condition
Hypertension, Coronary artery disease, Heart failure, Chronic kidney disease, Atrial fibrillation, High risk vascular disease, Cerebrovascular accident, Diabetes mellitus, High normal blood pressure, Pre-hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The risk of cancer from Renin-angiotensin-system (RAS)-acting agents has been much debated. However, few randomized clinical trials (RCTs) have directly compared RAS-acting agents. Furthermore, the true cancer risk of angiotensin receptor-neprilysin inhibitor (ARNI) is unknown. A network meta-analysis is the best analytical technique to enable indirect comparison among these agents. Therefore, we will conduct systematic review and network meta-analysis to assess the association between ARNI and cancer risk in a comprehensive analysis of data from RCTs.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The odds ratio (OR) of cancer with ARNI will be calculated. Network meta-analysis will be performed to compare the incidence of cancer between ARNI and control treatment. We will use five comparison categories: placebo, ARNI, angiotensin-converting-enzyme inhibitors (ACEi), angiotensin-receptor blockers (ARBs), ACEi and ARBs.
Key secondary outcomes
The odds ratio (OR) of cancer with ACEi, ARBs, ACEi and ARBs will be calculated. The main analysis will be compared individual drug classes with placebo, which will be used as reference.
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
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 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) RCTs including RAS-acting agents and control treatment in adult patients. Controls will be classified as placebo or non-placebo. Non-placebo drugs will be defined as any RAS-acting agents.
(2) The study with multiple arms where RAS-acting agent is included at least one arm.
(3) The study illustrates the safety outcome of cancer.
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 cancers listed in inclusion criteria.
(6) Studies with no or insufficient safety outcomes at the time of the literature search.
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.
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 Medical Science and Cardiorenal Medicine
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 Medical Science and Cardiorenal Medicine
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
Yokohama City University Graduate School of Medicine
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
045-787-2635
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
| 2022 | Year | 07 | Month | 18 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 07 | Month | 18 | Day |
Date of IRB
| 2022 | Year | 07 | Month | 18 | Day |
Anticipated trial start date
| 2022 | Year | 07 | Month | 18 | 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
We will search for candidate articles using PubMed, Cochrane, EMBASE, and Web of Science Core Collection in August 2022. A hand search will be conducted by two investigators.
RCTs meeting the following criteria will be considered for inclusion:
Participants: Adult patients.
Intervention: At least one RAS-acting agent (ARNI, ACEi, ARBs, ACEi and ARBs) will be included. Standard dose of RAS-acting agents will be included.
Comparison: Controls will be classified as placebo or non-placebo. Non-placebo drugs will be defined as any RAS-acting agents.
Outcomes: Overall incidence of cancers with RAS-acting agents during the observational period will be the collected.
A random model network meta-analysis will be performed.
Quality assessment:
The risk of bias of each study will be assessed by Cochrane risk of bias (RoB) tool for RCTs.
Subgroup analysis:
Subgroup analyses based on tumor type will be performed.
Management information
Registered date
| 2022 | Year | 07 | Month | 18 | Day |
Last modified on
| 2024 | Year | 02 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055165
