UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041311
Receipt No. R000047169
Scientific Title Organization of medical knowledge by intelligence science
Date of disclosure of the study information 2020/08/06
Last modified on 2021/08/11

* 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 Organization of medical knowledge by intelligence science
Acronym Omniscience-01
Scientific Title Organization of medical knowledge by intelligence science
Scientific Title:Acronym Omniscience-01
Region
Japan

Condition
Condition Advanced Solid Malignancies
Classification by specialty
Hematology and clinical oncology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 Identify the usefulness of QA Commons in generating treatment recommendations based on genetic variants and clinical information detected by gene panel testing
Basic objectives2 Others
Basic objectives -Others usability
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1.Agreement rate of evidence Level between the draft QA Commons report and EP
2.Agreement rate of drug reachability between the draft QA Commons report and EP
3.Agreement rate of Secondary Findings between the draft QA Commons report and EP
Key secondary outcomes a.Association of cancer gene panel test results with clinicopathological factors and clinical course
b.Differences in expert panel prep time with and without QA Commons
c.Satisfaction of Annotators on Expert Panels

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 Eligibility criteria are cases that meet all of the following 1.) to 3.) criteria to be considered eligible cases.
1,) Diagnosed with a solid malignancy.
2,) Be at least 20 years old.
3,) fall under a. or b. below.
a. Cohort A (Retrospective cohort)
Consent to the FoundationOne CDx Cancer Genome Profile at the National Cancer Institute East Hospital between June 2019 and February 2021, with insurance coverage.
b. Cohort B (Prospective cohort)
Consent to the FoundationOne CDx Cancer Genome Profile at the National Cancer Center East Hospital on or after March 2021, with written consent to participate in this study.

Key exclusion criteria The exclusion criteria were cases that were deemed inappropriate for enrollment in this study by the attending physician.
Target sample size 600

Research contact person
Name of lead principal investigator
1st name yoshiaki
Middle name
Last name nakamura
Organization National Cancer Center Hospital East
Translational Research Management Division, Clinical Research Support Office
Division name Translational Research Support Section
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL 04-7133-1111
Email yoshinak@east.ncc.go.jp

Public contact
Name of contact person
1st name takao
Middle name
Last name fujisawa
Organization National Cancer Center Hospital East
Division name Head and neck medical oncology
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba
TEL 04-7133-1111
Homepage URL
Email tafujisa@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East
Institute
Department

Funding Source
Organization Genomedia inc.
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 National Cancer Center Research Ethics Review Committee
Address 5-1-1 Tsukiji, Chuo, Tokyo
Tel 03-3542-2511
Email 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
2020 Year 08 Month 06 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
2020 Year 08 Month 04 Day
Date of IRB
2020 Year 10 Month 12 Day
Anticipated trial start date
2020 Year 10 Month 12 Day
Last follow-up date
2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Research design: Observational study
Eligibility: Patients with FoundationOne CDx Cancer Genome Profiles performed by insurance

Management information
Registered date
2020 Year 08 Month 04 Day
Last modified on
2021 Year 08 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047169

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.