UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021015 |
|---|---|
| Receipt number | R000024254 |
| Scientific Title | Verifying the early diagnostic method of adenovirus-induced hemorrhagic cystitis after allogeneic hematopoietic stem cells transplantation |
| Date of disclosure of the study information | 2016/02/14 |
| Last modified on | 2019/03/28 20:54:48 |
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Basic information
Public title
Verifying the early diagnostic method of adenovirus-induced hemorrhagic cystitis after allogeneic hematopoietic stem cells transplantation
Acronym
Early diagnosis of adenovirus-induced hemorrhagic cystitis after allo-HSCT
Scientific Title
Verifying the early diagnostic method of adenovirus-induced hemorrhagic cystitis after allogeneic hematopoietic stem cells transplantation
Scientific Title:Acronym
Early diagnosis of adenovirus-induced hemorrhagic cystitis after allo-HSCT
Region
| Japan |
Condition
Condition
adenovirus-induced hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation
Classification by specialty
| Hematology and clinical oncology | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study will prospectively examine urinary adenoviral DNA over time to inspect an early diagnostic method of adenovirus-induced hemorrhagic cystitis after allogeneic hematopoietic stem cell transplantation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The efficacy of quantifying urinary adenoviral DNA for diagnosis of adenovirus-induced hemorrhagic cystitis
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
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene |
Interventions/Control_1
Urinary adenoviral DNA is quantified in accordance with the schedule below.
1. Before the start of conditioning chemotherapy
2. Every two weeks after allogeneic hematopoietic stem cell transplantation
3. In case hemorrhagic cystitis has been developed, every week until improvement
4. At the outpatient clinic, once a month until one year post HSCT
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients who have a plan to undergo allogeneic hematopoietic stem cell transplantation
2. Patients who are going to be hospitalized for at least four weeks
3. Patients who agree in writing
Key exclusion criteria
1. Patients whom hemorrhagic cystitis has already developed
2. Patients who are recognized as inadaptable for this trial
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinji Nakao |
Organization
Kanazawa University Hospital
Division name
Department of Hematology
Zip code
Address
13-1, Takara-machi, Kanzawa, Ishikawa
TEL
076-234-2275
snakao8205@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yukio Kondo |
Organization
Kanazawa University Hospital
Division name
Department of Hematology
Zip code
Address
13-1, Takara-machi, Kanzawa, Ishikawa
TEL
076-234-2275
Homepage URL
y-kondo@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Department of Hematology, Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Hematology, Kanazawa University Hospital
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
Address
Tel
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
| 2016 | Year | 02 | Month | 14 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 02 | Month | 19 | Day |
Date of IRB
| 2013 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2016 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2019 | 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
| 2016 | Year | 02 | Month | 14 | Day |
Last modified on
| 2019 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024254
