UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000052976
Receipt number R000060438
Scientific Title Comparison of detection sensibility in various specimen collection methods in respiratory infectious pathogens
Date of disclosure of the study information 2023/12/06
Last modified on 2024/12/17 15:50:07

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Basic information

Public title

Comparison of detection sensibility in various specimen collection methods in respiratory infectious pathogens

Acronym

Comparison of detection sensibility in various specimen collection methods in respiratory infectious pathogens

Scientific Title

Comparison of detection sensibility in various specimen collection methods in respiratory infectious pathogens

Scientific Title:Acronym

Comparison of detection sensibility in various specimen collection methods in respiratory infectious pathogens

Region

Japan


Condition

Condition

none

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aims to compare the detection sensibility of four methods for collecting respiratory infectious pathogens from Japanese patients with respiratory infectious diseases. Four types of specimens (nasopharyngeal swabs, nasal swabs, nasal discharge, and saliva) will be collected from study subjects immediately after the onset of common cold-like symptoms and be subjected to multiplex PCR testing for more than 10 kinds of pathogens that cause respiratory infections. For specimens in which the pathogens are detected, the detection sensibility will be compared. In future vaccine development, the results of this study will help in selecting a highly sensitive detection method suitable for Japanese patients with respiratory infectious diseases in disease prevention studies.

Basic objectives2

Others

Basic objectives -Others

not applicable

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Detection sensibility in various specimen collection methods

Key secondary outcomes



Base

Study type

Observational


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

50 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

<Cohort A>
1.Subjects who have given written consent.
2.Japanese males or females aged 50 years or older at the time of informed consent.
3.Subjects who are able to call the study site immediately when they experience at least two of common cold-like symptoms, to collect the specimen by themselves within 6 hours from the time they experience the second symptoms, and to visit the study site on the designated date (within 72 hours from the time they experience the second symptoms).
Common cold-like symptoms are:
Nasal discharge, nasal congestion, pharyngeal pain, cough, wheezing, sputum, shortness of breath, or body temperature of 37.5 degrees or higher.
4.Subjects who are able to visit the study site within the designated period (3, 6, 9 and 12 months after the consent, and the end visit). When the number of subjects reaches the target, the study will be terminated early. In such a case, the end visit will be performed within 30 days after the termination date, and the three-monthly visits mentioned above will no longer be required.

<Cohort B>
1.Subjects who have given written consent.
2.Japanese males or females aged 50 years or older at the time of informed consent.
3.Subjects who have at least two of common cold-like symptoms and are able to visit the study site within 72 hours of the onset of the second symptoms.
Common cold-like symptoms are:
Nasal discharge, nasal congestion, pharyngeal pain, cough, wheezing, sputum, shortness of breath, or body temperature of 37.5 degrees or higher.

Key exclusion criteria

Subjects who are assessed as ineligible for the study by the principal investigator or sub-investigator.

Target sample size

1000


Research contact person

Name of lead principal investigator

1st name Hidetoshi
Middle name
Last name Furuie

Organization

Medical Corporation Heishinkai OPHAC Hospital

Division name

none

Zip code

532-003

Address

4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka

TEL

06-6395-9000

Email

hidetoshi.furuie@heishinkai.com


Public contact

Name of contact person

1st name Hidetoshi
Middle name
Last name Furuie

Organization

Medical Corporation Heishinkai OPHAC Hospital

Division name

none

Zip code

532-0003

Address

4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka

TEL

06-6395-9000

Homepage URL


Email

hidetoshi.furuie@heishinkai.com


Sponsor or person

Institute

others

Institute

Department

Personal name



Funding Source

Organization

Others

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

InCROM Inc.

Address

4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka

Tel

06-6395-9000

Email

sumiko.kawamoto@heishinkai.com


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 12 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

No longer recruiting

Date of protocol fixation

2023 Year 11 Month 27 Day

Date of IRB

2023 Year 12 Month 01 Day

Anticipated trial start date

2023 Year 12 Month 15 Day

Last follow-up date

2025 Year 02 Month 28 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

none


Management information

Registered date

2023 Year 12 Month 01 Day

Last modified on

2024 Year 12 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060438