UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053990 |
|---|---|
| Receipt number | R000060605 |
| Scientific Title | Academia Assembly Registry Study |
| Date of disclosure of the study information | 2024/03/28 |
| Last modified on | 2024/03/28 10:03:33 |
* 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
Academia Assembly Registry Study
Acronym
Academia Assembly Registry Study
Scientific Title
Academia Assembly Registry Study
Scientific Title:Acronym
Academia Assembly Registry Study
Region
| Japan |
Condition
Condition
Solid tumor
Classification by specialty
| Medicine in general | Gastroenterology | Hepato-biliary-pancreatic medicine |
| Pneumology | Hematology and clinical oncology | Nephrology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The case information (patient background, clinical course, genomic test results, etc.) of patients who have undergone cancer genome medicine will be registered, and the profile of genomic abnormalities will be explored.
Basic objectives2
Others
Basic objectives -Others
The data will be provided for the development of medical devices and the assurance and improvement of the quality of academia as secondary use.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Profile of genomic abnormalities in registered patients (percentage of evidence level A/B/R in the Guidance for Cancer Treatment based on gene panel tests using next-generation sequencers version 2.1)
Key secondary outcomes
Relationship between the profile of genomic abnormalities and clinical course, etc.
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)Written consent has been obtained.
2)18 years of age or older
3)have undergone or consented to undergo cancer genome profiling testing at a collaborating institution
Key exclusion criteria
1)Judged by physician to be unsuitable for enrolment in the study.
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yoichi |
| Middle name | |
| Last name | Naito |
Organization
National Cancer Center Hospital East
Division name
Department of General Internal Medicine
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
assembly-jimukyoku@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Nobuyuki |
| Middle name | |
| Last name | Takahashi |
Organization
National Cancer Center Hospital East
Division name
Department of Medical Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
Homepage URL
assembly-jimukyoku@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
Pfizer
IRB Contact (For public release)
Organization
National Cancer Center Institutional Review Board
Address
5-1-1, Tsukiji, Chuo ku, Tokyo, Japan
Tel
03-3542-2511
NCC_IRBoffice@ml.res.ncc.go.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 | 03 | Month | 28 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2034 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study Design: Observational study
Target population:the patients who meet the selection criteria until March 31 2033 from research permit date
Management information
Registered date
| 2024 | Year | 03 | Month | 28 | Day |
Last modified on
| 2024 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060605
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
