UMIN-ICDS Clinical Trial

Public title

Inflammatory Disorders Associated with Trisomy 8: Systematic Review

Acronym

Inflammatory Disorders Associated with Trisomy 8: Systematic Review

Scientific Title

Inflammatory Disorders Associated with Trisomy 8: Systematic Review

Scientific Title:Acronym

Inflammatory Disorders Associated with Trisomy 8: Systematic Review

Region

Japan

Condition

Patients with trisomy 8 consistently present with auto-inflammatory syndrome

Classification by specialty

Medicine in general	Hematology and clinical oncology	Clinical immunology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

In recent years, numerous associations between trisomy 8 and autoinflammatory diseases have been reported; however, their manifestations are diverse, and it can take time to make a diagnosis. Therefore, we will conduct a systematic review with the aim of characterizing patients who are trisomy 8-positive and present with autoinflammatory pathology.

Basic objectives2

Others

Basic objectives -Others

Analysis of the clinical features

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary endpoints are fever, oral ulcers, genital ulcers, skin lesions, arthralgia, and intestinal lesions. The frequency of each symptom is calculated.

Key secondary outcomes

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

18

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Case reports, case series, case-control studies, and cohort studies are eligible.
(2) Studies with clinically diagnosed autoinflammatory conditions associated with trisomy 8 will be eligible.
(3) Studies describing fever, oral ulcers, genital ulcers, skin lesions, arthralgias, and intestinal lesions will be eligible.

Key exclusion criteria

(1) Systematic review or meta-analysis articles.
(2) Republished research literature will be excluded unless it contains new findings related to autoinflammatory conditions.
(3) Studies published in languages other than English.

Target sample size

Name of lead principal investigator

1st name	Kaoru
Middle name
Last name	Minegishi

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Stem Cell and Immune Regulation

Zip code

236-0004

Address

3-9, Kanazawa, Fukuura, Yokohama

TEL

045-787-2630

Email

kaoru_t@yokohama-cu.ac.jp

Name of contact person

1st name	Kaoru
Middle name
Last name	Minegishi

Organization

Yokohama City University Graduate School of Medicine

Division name

Department of Stem Cell and Immune Regulation

Zip code

236-0004

Address

3-9, Kanazawa, Fukuura, Yokohama

TEL

045-787-2630

Homepage URL

Email

kaoru_t@yokohama-cu.ac.jp

Institute

Yokohama City University Graduate School of Medicine

Institute

Department

Personal name

Organization

Yokohama City University Graduate School of Medicine

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Yokohama City University Graduate School of Medicine

Address

3-9, Kanazawa, Fukuura, Yokohama

Tel

045-787-2630

Email

kaoru_t@yokohama-cu.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

12

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Preinitiation

Date of protocol fixation

2023

Year

12

Month

14

Day

Date of IRB

Anticipated trial start date

2023

Year

12

Month

15

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 related information

Candidate papers will be searched in December 2023 using PubMed, Cochrane, EMBASE, and Web of Science Core Collection. Hand searches will be conducted by two people.
Two people will independently review all titles, abstracts, and full texts for eligibility. Final inclusion will be determined after resolution of any discrepancies between the two investigators.

Participants: Patients with trisomy 8-positive autoinflammatory pathology
Intervention: None
Comparison: None
Outcome: Fever, oral ulcers, genital ulcers, skin lesions, arthralgia, presence of intestinal complications

Risk of bias for each study will be assessed with the Newcastle-Ottawa Scale for cohort studies.

Registered date

2023

Year

12

Month

14

Day

Last modified on

2023

Year

12

Month

14

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060596