UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044278 |
|---|---|
| Receipt number | R000050564 |
| Scientific Title | Exploratory study on mechanism of action and immune-related biomarkers in patients with salivary gland cancer who received trastuzumab delxtecan |
| Date of disclosure of the study information | 2021/07/31 |
| Last modified on | 2024/04/18 14:30:40 |
* 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
Exploratory study on mechanism of action and immune-related biomarkers in patients with salivary gland cancer who received trastuzumab delxtecan
Acronym
Exploratory study on mechanism of action and immune-related biomarkers in patients with salivary gland cancer who received trastuzumab delxtecan
Scientific Title
Exploratory study on mechanism of action and immune-related biomarkers in patients with salivary gland cancer who received trastuzumab delxtecan
Scientific Title:Acronym
Exploratory study on mechanism of action and immune-related biomarkers in patients with salivary gland cancer who received trastuzumab delxtecan
Region
| Japan |
Condition
Condition
salivary gland carcinoma
Classification by specialty
| Not applicable |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Search for biomarkers related in the efficacy of trastuzumab delxtecan therapy
Basic objectives2
Others
Basic objectives -Others
Patients who have obtained consent in this study and treated with trastuzumab deruxtecan are entered in the study.
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Immune cell profile analysis
Genome mutation analysis
mRNA expression analysis
Proteomics analysis
Multicolor IHC analysis
AI pathological analysis
Blood cfDNA analysis
Blood cfRNA / miRNA analysis, etc.
Key secondary outcomes
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
Subjects treated with trastuzumab deruxtecan in Investigator Initiated Study of trastuzumab deruxtecan for salivary gland cancer
Key exclusion criteria
No criteria
Target sample size
52
Research contact person
Name of lead principal investigator
| 1st name | Hirotoshi |
| Middle name | |
| Last name | Akita |
Organization
Hokkaido University Hospital
Division name
Medical Oncology
Zip code
060-8648
Address
North 14 West 5, Kita-ku, Sapporo, Hokkaido, Japan
TEL
0117061161
hdakita@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Tomoko |
| Middle name | |
| Last name | Terada |
Organization
Hokkaido University Hospital
Division name
Clinical Research and Medical Innovation Center
Zip code
060-8648
Address
North 14 West 5, Kita-ku, Sapporo, Hokkaido, Japan
TEL
0117067735
Homepage URL
tr_ds-8201a_jimu@pop.med.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Medical oncology
Institute
Department
Personal name
Funding Source
Organization
Daiichi Sankyo Company Limited
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
North 14 West 5, Kita-ku, Sapporo, Hokkaido, Japan
Tel
0117067636
crjimu@huhp.hokudai.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
| 2021 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 26 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Using Tumor and blood samples, analyzing the relationship between gene expression, immune profile and therapeutic effect, and exploring biomarkers involved in the efficacy of trastuzumab deruxtecan therapy.
Management information
Registered date
| 2021 | Year | 05 | Month | 21 | Day |
Last modified on
| 2024 | Year | 04 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050564
