UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048702 |
|---|---|
| Receipt number | R000055491 |
| Scientific Title | Matched case control study investigating the association between HLA alleles and severe cutaneous adverse reactions suspected of being the effect of Atezolizumab |
| Date of disclosure of the study information | 2022/08/19 |
| Last modified on | 2023/08/02 17:29:10 |
* 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
Matched case control study investigating the association between HLA alleles and severe cutaneous adverse reactions suspected of being the effect of Atezolizumab
Acronym
Matched case control study investigating the association between HLA alleles and severe cutaneous adverse reactions suspected of being the effect of Atezolizumab (CMA-0173)
Scientific Title
Matched case control study investigating the association between HLA alleles and severe cutaneous adverse reactions suspected of being the effect of Atezolizumab
Scientific Title:Acronym
Matched case control study investigating the association between HLA alleles and severe cutaneous adverse reactions suspected of being the effect of Atezolizumab (CMA-0173)
Region
| Japan |
Condition
Condition
Malignancy
Classification by specialty
| Hepato-biliary-pancreatic medicine | Pneumology | Hepato-biliary-pancreatic surgery |
| Chest surgery | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Association between Severe cutaneous adverse reactions (SCAR) suspected of being the effect of Atezolizumab and several previously selected HLA alleles will each be examined.
Basic objectives2
Others
Basic objectives -Others
The association between SCAR and several previously selected HLA alleles
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Presence of previously selected, identified HLA alleles
Key secondary outcomes
Genetic predisposition associated with the occurrence of a SCAR
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients who develop a severe cutaneous adverse reaction (SCAR) after receiving treatment with atezolizumab in actual clinical practice (including clinical research other than a clinical study)
(2) Patients who provide their informed consent in writing for participation in this study.
(3) Aged at least 18 years old when consent is obtained
(4) Patients who are able to provide samples (blood, etc.) for the HLA allele tests.
Key exclusion criteria
Not applicable
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Nishi |
Organization
Chugai Pharmaceutical Co., Ltd.
Division name
Medical Affairs Div.
Zip code
103-0022
Address
2-1-1 Muromachi, Nihonbashi, Chuo-ku, Tokyo Japan
TEL
03-3273-0866
cma-clinicaltrial@chugai-pharm.co.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Masai |
Organization
SRL Medisearch Inc.
Division name
Clinical Research Div.
Zip code
163-0408
Address
Shinjuku Mitsui Building, 2-1-1 Nishishinjuku, Shinjuku-ku, Tokyo Japan
TEL
050-2000-5231
Homepage URL
hideki.masai@hugp.com
Sponsor or person
Institute
Chugai Pharmaceutical Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee for research using human-derived samples
Address
2-1-1 Muromachi, Nihonbashi, Chuo-ku, Tokyo Japan
Tel
03-3281-6611
cma-clinicaltrial@chugai-pharm.co.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
| 2022 | Year | 08 | Month | 19 | 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
| 2022 | Year | 07 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2022 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Evaluate the association between SCAR suspected of being the effect of Atezolizumab and several previously selected HLA alleles
Management information
Registered date
| 2022 | Year | 08 | Month | 19 | Day |
Last modified on
| 2023 | Year | 08 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055491
