UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049428 |
|---|---|
| Receipt number | R000056279 |
| Scientific Title | A Multicenter Observational Study of Whole Genome Analysis for patient benefit |
| Date of disclosure of the study information | 2022/11/04 |
| Last modified on | 2024/05/06 11:25:24 |
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Basic information
Public title
A Multicenter Observational Study of Whole Genome Analysis for patient benefit
Acronym
A Multicenter Observational Study of Whole Genome Analysis for patient benefit
Scientific Title
A Multicenter Observational Study of Whole Genome Analysis for patient benefit
Scientific Title:Acronym
A Multicenter Observational Study of Whole Genome Analysis for patient benefit
Region
| Japan |
Condition
Condition
cancer
Classification by specialty
| Hematology and clinical oncology | Adult |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
This project targets patients who have undergone whole-genome analysis in the AMED Innovative Cancer Research (Area 1-7) "Research in Cancer Whole Genome Analysis for patients." in FY2021.
We will explore the possibility of returning the results of whole genome analysis to patients with advanced or refractory cancer who are enrolled in the basic cohort, using information entered into Electronic Data Capture (EDC).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of patients with advanced or refractory cancer linked to treatment after whole genome analysis
Key secondary outcomes
Percentage of patients who will be diagnosed after whole genome analysis in particularly difficult-to-diagnose cancer types, including rare cancers.
Percentage of patients for whom a heritable disease-associated pathological variant is extracted by whole genome analysis
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with cancer, who underwent whole genome analysis in the "Research in Whole Genome Analysis of Cancer for patient"
Key exclusion criteria
none
Target sample size
5000
Research contact person
Name of lead principal investigator
| 1st name | Noboru |
| Middle name | |
| Last name | Yamamoto |
Organization
National cancer center Hospital
Division name
Department of experimental development
Zip code
1040045
Address
5-1-1 Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
nbryamam@ncc.go.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Katsuya |
Organization
National Cancer Center Hospital
Division name
Department of experimental development
Zip code
104-0045
Address
5-1-1, Tsukiji, Chuo-ku, Tokyo
TEL
0335422511
Homepage URL
ykatsuya@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
AMED
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National cancer center
Address
5-1-1, Tsukiji, Chuo-ku
Tel
0335422511
irst@ml.res.ncc.go.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2022-155
Org. issuing International ID_1
Natinal cancer center
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 | 11 | Month | 04 | 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
| 2022 | Year | 07 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 09 | Month | 27 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 04 | Day |
Last follow-up date
| 2029 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Using the data entered into the EDC, the clinical utility of whole genome analysis for patients with advanced or refractory cancer (e.g., whether it leads to higher drug reach rates or higher diagnosis rates in rare cancers) will be examined.
Management information
Registered date
| 2022 | Year | 11 | Month | 04 | Day |
Last modified on
| 2024 | Year | 05 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056279
