UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054506 |
|---|---|
| Receipt number | R000062268 |
| Scientific Title | Early Diagnosis of Virus Infection by Digital PCR |
| Date of disclosure of the study information | 2024/07/31 |
| Last modified on | 2024/05/29 23:29:55 |
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Basic information
Public title
Early Diagnosis of Virus Infection by Digital PCR
Acronym
The development of new diagnostic method of virus infection
Scientific Title
Early Diagnosis of Virus Infection by Digital PCR
Scientific Title:Acronym
Early Diagnosis of Virus Infection by Digital PCR
Region
| Japan |
Condition
Condition
Hematopoietic disease
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Validate the effectiveness of digital PCR to diagnose virus infection of hematopoietic disease patients
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Consistency of digital PCR to conventional PCR
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
Collect nasal swab and sputum which is beyond regular treatment
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
Patient eligibility: all patients who have indications to allogeneic and autologous hematopoietic stem cell transplantation who meet all of the following criteria.
1) Patients of hematopoietic malignancy or of non-neoplastic hematopathy
2) Age over 18 years
3) Do not show the symptoms of active infection before starting conditioning treatment.
4) The indication of transplantation includes autologous bone marrow transplantation, autologous peripheral stem cell transplantation, allogenic bone marrow transplantation, allogenic peripheral stem cell transplantation, umbilical cord blood transplantation.
5) There is no limitation to conditioning treatment.
6) There is no limitation to prevention method of GVHD.
7) Submitted written informed consents.
Key exclusion criteria
There are no exclusion criteria.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Arai |
Organization
St. Marianna University Hospital
Division name
Hematology
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-Ku, Kawasaki
TEL
044-977-8111
ara.hema@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Arai |
Organization
St. Marianna University School of Medicine
Division name
Department of Hematology & Oncology
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-Ku, Kawasaki
TEL
044-977-8111
Homepage URL
ara.hema@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University Hospital
Institute
Department
Personal name
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Bioethics Committee (Clinical Trials Subcommittee)
Address
2-16-1 Sugao, Miyamae-Ku, Kawasaki
Tel
044-977-8111
k-sienbu.mail@marianna-u.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
| 2024 | Year | 07 | Month | 31 | 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
| 2024 | Year | 05 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 05 | Month | 29 | Day |
Last modified on
| 2024 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062268
