UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056533 |
|---|---|
| Receipt number | R000064603 |
| Scientific Title | Prospective study to investigate the clinical significance of cancer whole-genome seqeuncing |
| Date of disclosure of the study information | 2024/12/21 |
| Last modified on | 2024/12/21 19:46:39 |
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Basic information
Public title
Prospective study to investigate the clinical significance of cancer whole-genome seqeuncing
Acronym
Prospective study to investigate the clinical significance of cancer whole-genome seqeuncing
Scientific Title
Prospective study to investigate the clinical significance of cancer whole-genome seqeuncing
Scientific Title:Acronym
Prospective study to investigate the clinical significance of cancer whole-genome seqeuncing
Region
| Japan |
Condition
Condition
Solid cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
At Kyoto University Hospital, genomic profiling through whole-genome analysis of tumor and non-tumor tissues will be conducted on cancer patients who are undergoing or may undergo treatment with cancer chemotherapy. This study aims to identify somatic gene mutations, gene expression patterns, and genetic polymorphisms associated with treatment efficacy and toxicity.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of actionable genomic alterations
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Patients with solid tumors who have undergone or are scheduled to undergo cancer chemotherapy.
(2) Individuals who are 18 years of age or older at the time of obtaining consent.
(3) Patients from whom at least one of the following types of tissue can be obtained:
A. Tumor tissue
Surplus biopsy or surgical specimens from patients treated at Kyoto University Hospital.
B. Normal tissue
Surplus biopsy or surgical specimens from patients treated at Kyoto University Hospital.
Surplus specimens from patients treated at Kyoto University Hospital.
Peripheral blood samples (20 mL) collected in addition to routine blood draws during regular clinical care.
Newly collected oral mucosal samples (oral swab) and saliva obtained specifically for this study.
C. Samples (biopsy specimens, surgical specimens, peripheral blood) from patients who have consented to the Clinical BioResource Center, Kyoto University Hospital's information document "Information on the Storage and Future Research Use of Biological Samples (approved by the Medical Faculty Council)."
Key exclusion criteria
Patients deemed unsuitable as research participants at the discretion of the principal investigator.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Manabu |
| Middle name | |
| Last name | Muto |
Organization
Kyoto University Hospital
Division name
Clinical Oncology
Zip code
606-8507
Address
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
0757513518
amed2024wgs@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomohiro |
| Middle name | |
| Last name | Kondo |
Organization
Kyoto University Hospital
Division name
Clinical Oncology
Zip code
606-8507
Address
54 Shogoin-Kawaharacho, Sakyo-ku, Kyoto 606-8507, Japan
TEL
0757513518
Homepage URL
amed2024wgs@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2024 | Year | 12 | Month | 21 | 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
| 2024 | Year | 09 | Month | 11 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2024 | Year | 12 | Month | 21 | Day |
Last modified on
| 2024 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064603
