UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052151 |
|---|---|
| Receipt number | R000059522 |
| Scientific Title | Construction of data for implementation of comprehensive cancer genome profiling using genome-guided system |
| Date of disclosure of the study information | 2023/09/08 |
| Last modified on | 2023/09/08 14:33:10 |
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Basic information
Public title
Construction of data for implementation of comprehensive cancer genome profiling using genome-guided system
Acronym
Construction of data for implementation of comprehensive cancer genome profiling using genome-guided system
Scientific Title
Construction of data for implementation of comprehensive cancer genome profiling using genome-guided system
Scientific Title:Acronym
Construction of data for implementation of comprehensive cancer genome profiling using genome-guided system
Region
| Japan |
Condition
Condition
Solid cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This study will construct data and create a track record of clinical implementation for solid tumor patients who underwent "comprehensive cancer genome profiling (cancer gene panel test)" at St. Marianna University Hospital and were annotated using Molecular Health's MH Guide system.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of patients for whom genome-guided treatment could be proposed among patients who underwent cancer gene panel testing at St. Marianna University Hospital and were analysed using the MH Guide for annotation based on measured data.
Key secondary outcomes
druggable genomic alterations
*Definition in the St. Marianna University Hospital Expert Panel: genomic alterations with evidence level C1 or higher or evidence level D2 and promising investigational drugs in the Guidance for cancer treatment based on gene panel testing using next-generation sequencers.
*Definition in the MH Guide: genomic alterations with a Biomarker score of 4 or more.
Time spent on annotation.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cases that meet all of the following are eligible
1. Solid cancer cases
2. Cases undergoing cancer gene panel testing using the MH Guide at St. Marianna University Hospital
Key exclusion criteria
Cases judged by the principal investigator to be inappropriate for participation in the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yu |
| Middle name | |
| Last name | Sunakawa |
Organization
St. Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
0449778111
y.sunakawa@marianna-u.ac.jp
Public contact
Name of contact person
| 1st name | Kiyomi |
| Middle name | |
| Last name | Imoto |
Organization
St. Marianna University Hospital
Division name
Centre for the Genomic Medicine
Zip code
216-8511
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
0449778111
Homepage URL
imoto@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Yu Sunakawa
Funding Source
Organization
St. Marianna University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Molecular Health GmbH
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB, St. Marianna University School of Medicine
Address
2-16-1, Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel
0449778111
k-sienbu.mail@marianna-u.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
| 2023 | Year | 09 | Month | 08 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 05 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
For eligible cases, the MH Guide will be used to annotate and prospectively collect data on the recommended treatment proposed by the expert panel, druggable gene alterations and time spent on annotation. In addition, patient background data on age, gender, cancer type, family history, treatment history, previous genomic testing results and post-expert panel treatment will be collected.
Analyses primary and secondary endpoints from the data collected.
Management information
Registered date
| 2023 | Year | 09 | Month | 08 | Day |
Last modified on
| 2023 | Year | 09 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059522
