UMIN-CTR Clinical Trial

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
Email	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
Email	nobuyuki_horita@yahoo.co.jp

Sponsor
Institute	Yokohama City University
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045302