UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046517 |
|---|---|
| Receipt number | R000053065 |
| Scientific Title | Incidence and risk of hypertension with immune checkpoint inhibitors in solid tumors |
| Date of disclosure of the study information | 2021/12/31 |
| Last modified on | 2023/07/18 23:32:17 |
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Basic information
Public title
Incidence and risk of hypertension with immune checkpoint inhibitors in solid tumors
Acronym
Systematic review
Scientific Title
Incidence and risk of hypertension with immune checkpoint inhibitors in solid tumors
Scientific Title:Acronym
Systematic review
Region
| Japan |
Condition
Condition
Solid tumors
Classification by specialty
| Cardiology | Nephrology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to assess the incidence and risk of hypertension in patients with solid tumors who received immune checkpoint inhibitor (ICI) treatment, by performing a meta-analysis of randomized controlled trials (RCTs).
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Any grade of hypertension of ICI therapy during the observational period will be the primary outcome of our study. In clinical trials of anti-cancer agents, hypertension is classified according to the Common Terminology Criteria for Adverse Events (CTCAE) system.
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
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) RCTs including ICI-containing arm and control arm in adult patients. Controls were classified as placebo or non-placebo. Non-placebo drugs were defined as any anticancer drugs.
(2) The study with multiple arms where ICI is included at least one arm.
(3) The study illustrates the outcome of hypertension.
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 adverse events 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 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
| 2021 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
https://www.ahajournals.org/doi/10.1161/HYPERTENSIONAHA.122.19865?url_ver=Z39.88-2003&rfr_id=ori:rid
Publication of results
Published
Result
URL related to results and publications
https://www.ahajournals.org/doi/10.1161/HYPERTENSIONAHA.122.19865?url_ver=Z39.88-2003&rfr_id=ori:rid
Number of participants that the trial has enrolled
19810
Results
Please refer to the following:
https://www.ahajournals.org/doi/10.1161/HYPERTENSIONAHA.122.19865?url_ver=Z39.88-2003&rfr_id=ori:rid
Results date posted
| 2023 | Year | 07 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Please refer to the following:
https://www.ahajournals.org/doi/10.1161/HYPERTENSIONAHA.122.19865?url_ver=Z39.88-2003&rfr_id=ori:rid
Participant flow
Please refer to the following:
https://www.ahajournals.org/doi/10.1161/HYPERTENSIONAHA.122.19865?url_ver=Z39.88-2003&rfr_id=ori:rid
Adverse events
Please refer to the following:
https://www.ahajournals.org/doi/10.1161/HYPERTENSIONAHA.122.19865?url_ver=Z39.88-2003&rfr_id=ori:rid
Outcome measures
Please refer to the following:
https://www.ahajournals.org/doi/10.1161/HYPERTENSIONAHA.122.19865?url_ver=Z39.88-2003&rfr_id=ori:rid
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 12 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | 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 January 2022. A hand search will be conducted by two investigators.
RCTs meeting the following criteria will be considered for inclusion:
Participants: The patients were clinically diagnosed with any solid tumor. Tumor type is not questioned since safety profile is not largely affected by cancer type as long as the same regimen was selected. Hematological diseases will be included.
Intervention: At least one ICI-containing arm will be included. Any regimens of ICI dose will be included.
Comparison: Controls were classified as placebo or non-placebo. Non-placebo drugs were defined as any anticancer drugs.
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. All available events in RCTs of ICIs reported on ClinicalTrials.gov will be extracted. If events of hypertension are not available on ClinicalTrials.gov, events will be extracted from published RCTs. All the dichotomous primary outcomes will be compared between the two treatment arms. We will use Review Manager 5.4.
Quality assessment:
The risk of bias of each study will be assessed by Cochrane risk of bias (RoB) tool for randomized trials.
Subgroup analysis:
Subgroup analyses based on the following subgroups will be performed for the primary outcome: (i) a subgroup of trials based on tumor type, (ii) a subgroup of trials based on ICI regimen, (iii) a subgroup limited to placebo controlled trials.
Management information
Registered date
| 2021 | Year | 12 | Month | 31 | Day |
Last modified on
| 2023 | Year | 07 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053065
