UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014412 |
|---|---|
| Receipt number | R000016766 |
| Scientific Title | Evaluation of oxidative stress markers in hematopoietic stem cell transplantation patients |
| Date of disclosure of the study information | 2014/06/29 |
| Last modified on | 2020/01/04 00:51:03 |
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Basic information
Public title
Evaluation of oxidative stress markers in hematopoietic stem cell transplantation patients
Acronym
Oxidative stress in HCT
Scientific Title
Evaluation of oxidative stress markers in hematopoietic stem cell transplantation patients
Scientific Title:Acronym
Oxidative stress in HCT
Region
| Japan |
Condition
Condition
Hematologic disease
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
to clarify the significance of oxidative stress markers in hematopoietic stem cell transplantation patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
relationship between oxidative stress markers and GVHD.
Key secondary outcomes
1) relationship between oxidative stress markers and other transplant-related complications.
2) relationship between oxidative stress markers and survival
3) relationship between oxidative stress markers and transplant-related mortality (TRM).
4) relationship between oxidative stress markers and total body irradiation (TBI).
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Candidates for hematopoietic stem cell transplantation.
Key exclusion criteria
Patients who could not obtain written consent.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Tomonori |
| Middle name | |
| Last name | Nakazato |
Organization
Yokohama Municipal Citizen's Hospital
Division name
Department of Hematology
Zip code
2408555
Address
56 Okazawacho, Hodogaya-ku, Yokohama, Kanagawa
TEL
045-331-1961
n-tomo@eurus.dti.ne.jp
Public contact
Name of contact person
| 1st name | Tomonori |
| Middle name | |
| Last name | Nakazato |
Organization
Yokohama Municipal Citizen's Hospital
Division name
Department of Hematology
Zip code
2408555
Address
56 Okazawacho, Hodogaya-ku, Yokohama, Kanagawa
TEL
045-331-1961
Homepage URL
n-tomo@eurus.dti.ne.jp
Sponsor or person
Institute
Yokohama Municipal Citizen's Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Yokohama Municipal Citizen's Hospital
Address
56 Okazawa-cho, Hodogaya-ku, Yokohama, Japan
Tel
0453311961
n-tomo@eurus.dti.ne.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
横浜市立市民病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 29 | Day |
Related information
URL releasing protocol
http://yokohama-shiminhosp.jp/
Publication of results
Published
Result
URL related to results and publications
http://yokohama-shiminhosp.jp/
Number of participants that the trial has enrolled
32
Results
19 male and 13 female patients with a median age of 58 years.
In 20 allo-HSCT patients, the urinary 8-OHdG levels at 1 week after the transplant were significantly higher than the pre-conditioning levels and the levels in healthy controls. In 12 auto-HSCT patients, the urinary 8-OHdG levels at Week 1 were also higher than the pre-conditioning levels. The relative increase in the urinary-8OHdG levels from pre- to post-transplant at Week 1 was associated with a poor overall survival in the allo-HSCT patients.
Results date posted
| 2020 | Year | 01 | Month | 04 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The patients were 19 male and 13 female patients with a median age of 58 years (27-68 years). Twenty patients received allogeneic HSCT and 12 patients received autologous HSCT.
Participant flow
After informed consent was obatained from each patient, urine samples were collected
We measured urinary 8-hydroxydeoxyguanosine (8-OHdG) by competitive immunochromatography using a novel automatic oxidative stress analyzer, ICR-001.
Adverse events
none
Outcome measures
1-year OS, high 8-OHdG group: 12.5% vs. low 8-OHdG group: 60.0%; P=0.005.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 08 | Month | 23 | Day |
Date of IRB
| 2012 | Year | 01 | Month | 16 | Day |
Anticipated trial start date
| 2012 | Year | 02 | Month | 14 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2015 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
serum and urine oxidative stress markers are measured before and after hematopoietic stem cell transplantation.
Management information
Registered date
| 2014 | Year | 06 | Month | 29 | Day |
Last modified on
| 2020 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016766
