UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029097 |
|---|---|
| Receipt number | R000033282 |
| Scientific Title | Identification of HLA haplotype in tumor cells, after relapse following allogeneic hematopoietic stem cell transplantation from a haploidentical donor for hematological malignancy |
| Date of disclosure of the study information | 2017/09/12 |
| Last modified on | 2021/09/14 09:35:25 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Identification of HLA haplotype in tumor cells, after relapse following allogeneic hematopoietic stem cell transplantation from a haploidentical donor for hematological malignancy
Acronym
Identification of HLA haplotype in relapsed tumor cells after haploidentical transplantation
Scientific Title
Identification of HLA haplotype in tumor cells, after relapse following allogeneic hematopoietic stem cell transplantation from a haploidentical donor for hematological malignancy
Scientific Title:Acronym
Identification of HLA haplotype in relapsed tumor cells after haploidentical transplantation
Region
| Japan |
Condition
Condition
relpased hematological malignancy after haploidnetical HSCT
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To detect the loss of mismatched haplotype which should have been attacked by donor cells, by the identification of relapsed tumor cells after haploidentical HSCT.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
the rate of the loss of mismatched haplotype in tumor cells after relapse
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
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
The identification of HLA haplotype in relapsed tumor cells after haploidentical 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
Relapsed patients after haploidentical HSCT for hematological malignancy.
Key exclusion criteria
None.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Kanda |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Division of Hematology
Zip code
330-8503
Address
1-847 Amanuma, Omiya-ku, Saitama-city, Saitama 330-8503, Japan
TEL
+81-48-647-2111
ycanda-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Kako |
Organization
Saitama Medical Center, Jichi Medical University
Division name
Division of Hematology
Zip code
330-8503
Address
1-847 Amanuma, Omiya-ku, Saitama-city, Saitama 330-8503, Japan
TEL
+81-48-647-2111
Homepage URL
shinichikako@asahi-net.email.ne.jp
Sponsor or person
Institute
Division of Hematology, Saitama Medical Center, Jichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Leukemia Research Fund
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
IRB of Jichi Medical University Saitama Medical Center
Address
1-847, Amanuma-cho, Omiya-ku , Saitama-shi, Saitama
Tel
+81-48-647-2111
m.kuroda@jichi.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
| 2017 | Year | 09 | Month | 12 | 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
Enrolling by invitation
Date of protocol fixation
| 2017 | Year | 08 | Month | 25 | Day |
Date of IRB
| 2017 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2017 | Year | 08 | Month | 25 | Day |
Last follow-up date
| 2021 | Year | 12 | 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
| 2017 | Year | 09 | Month | 11 | Day |
Last modified on
| 2021 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033282
