UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039721 |
|---|---|
| Receipt number | R000045302 |
| Scientific Title | ABO blood groups as risk factor of tuberculosis: network meta-analysis. |
| Date of disclosure of the study information | 2020/03/06 |
| Last modified on | 2021/12/07 17:45:13 |
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Basic information
Public title
ABO blood groups as risk factor of tuberculosis: network meta-analysis.
Acronym
ABO blood groups as risk factor of tuberculosis: network meta-analysis.
Scientific Title
ABO blood groups as risk factor of tuberculosis: network meta-analysis.
Scientific Title:Acronym
ABO blood groups as risk factor of tuberculosis: network meta-analysis.
Region
| Japan |
Condition
Condition
Tuberculosis
Classification by specialty
| Pneumology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Tuberculosis infection is a communicable disease caused by Mycobacterium tuberculosis, which spread from person to person through the air. Globally, an estimated 1.5 million people died out of 10 million tuberculosis (TB) cases. Well-established risk factors for TB infection includes human immunodeficiency virus infection, malnutrition, diabetes, alcohol abuse, use of immunosuppressive drugs, and exposure to tobacco smoke.
The ABO blood group was originally discovered for a safe blood transfusion in early 20th century. Each of two allele has antigen A, B, or null status. A combination of these alleles determines blood type of an individual (types A, B, AB, and O). Since its discovery, there has been an ongoing interest in the potential role of ABO blood groups in infectious disease. People with a specific blood group have an increased or decreased risk of some infectious diseases. For example, while a person with blood type O appeared to be more susceptible to norovirus infection, individuals who do not have blood type O are more susceptible to schistosomiasis. Individuals with B and AB blood group are reported less likely to be infected with H. pylori. Likewise, many researches have conducted to clarify how ABO blood groups affect the risk of tuberculosis. Nonetheless, we could not reach the conclusion because of discrepant result among studies.
Basic objectives2
Others
Basic objectives -Others
We planned this systematic review to assess the association between ABO blood group and risk of tuberculosis infection.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
An ABO blood group with the lowest odds for tuberculosis will be selected as a common comparator. Then, odds ratio will be calculated for the other three blood groups using a network meta-analysis manner.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
We will divide Tuberculosis patients and controls into four ABO blood groups.
Key exclusion criteria
Not applicable.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Horita |
Organization
Yokohama City University
Division name
Department of Pulmonology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa, Yokohama, Japan
TEL
045-787-2800
nobuyuki_horita@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Horita |
Organization
Yokohama City University
Division name
Department of Pulmonology
Zip code
236-0004
Address
3-9, Fukuura, Kanazawa, Yokohama, Japan
TEL
045-787-2800
Homepage URL
nobuyuki_horita@yahoo.co.jp
Sponsor or person
Institute
Yokohama City University
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University
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
IRB not required
Address
IRB not required
Tel
0000000000
dummy@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
| 2020 | Year | 03 | Month | 06 | 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
Main results already published
Date of protocol fixation
| 2020 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study search
We will use the following search formulas.
Pubmed: ((abo [title] OR blood type [title] or blood group [title]) (tuberculosis or tb)) OR ((abo OR "blood type" or "blood group") (tuberculosis [title] or tb[title]))
Published
Int J Infect Dis. 2021 Mar;104:701-707.
Patients
We will divide Tuberculosis patients and controls into four ABO blood groups.
Analyses
The number of patients and controls will be compared between the two blood groups using the odds ratio (OR). If one or more cells in two-by-two contingency are null, 0.5 will be added to all cells.
The logarithm of OR and its standard error (SE) will be pooled using the frequentist weighted least squares approach random-model network meta-analysis using the "netmeta" command in "netmeta" package of R. A league table for OR accompanied with a 95% confidence interval (95% CI) will be presented.
A pairwise meta-analysis comparing two ABO blood groups using a group with the lowest odds for tuberculosis as a common comparator will also be conducted.
Management information
Registered date
| 2020 | Year | 03 | Month | 06 | Day |
Last modified on
| 2021 | Year | 12 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045302
