UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052285 |
|---|---|
| Receipt number | R000059686 |
| Scientific Title | Hypertension and the risk of developing cancer: a systematic review and meta-analysis |
| Date of disclosure of the study information | 2023/10/01 |
| Last modified on | 2024/03/04 23:54:40 |
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Basic information
Public title
Hypertension and the risk of developing cancer: a systematic review and meta-analysis
Acronym
Hypertension and the risk of developing cancer: a systematic review and meta-analysis
Scientific Title
Hypertension and the risk of developing cancer: a systematic review and meta-analysis
Scientific Title:Acronym
Hypertension and the risk of developing cancer: a systematic review and meta-analysis
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Medicine in general | Cardiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
A systematic review and meta-analysis of the risk of developing solid tumors in hypertensive patients
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary endpoint is the risk of developing solid tumors in hypertensive patients. Hazard ratios (HRs) will be calculated for the incidence of solid tumors in hypertensive patients and normotensive patients.
Key secondary outcomes
The secondary endpoint is the risk of developing solid tumors in untreated hypertensive patients.
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
(1) The studies are case-control studies, cohort studies, and randomized clinical trials.
(2) The studies are of patients with clinically diagnosed hypertension.
(3) It includes a normotensive group as a control.
(4) The study describes the complication of malignancy.
Key exclusion criteria
We will examine whether cancer risk is higher in people with hypertension. Drug use and cancer risk, such as antihypertensive medications, will be excluded. The search will be limited to solid tumors because blood cancers are rare in this topic.
In addition, the following items will be used as exclusion criteria.
(1) Systematic review or meta-analysis articles.
(2) Case reports or case series reporting less than 50 cases.
(3) The republished research literature is excluded unless the research includes new findings related to malignancy outcomes.
(4) Studies published in languages other than English.
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
We will 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.
Participants: The patients were clinically diagnosed with hypertension.
Intervention: No intervention.
Comparison: Normotensive persons.
Outcome: Incidence of malignant tumors.
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.
The risk of bias of each study will be assessed by the Newcastle-Ottawa Scale for cohort studies.
Subgroup analysis:
Subgroup analysis based on tumor type will be performed for the primary and secondary outcomes.
Management information
Registered date
| 2023 | Year | 09 | Month | 22 | Day |
Last modified on
| 2024 | Year | 03 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059686
