UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049417 |
|---|---|
| Receipt number | R000056267 |
| Scientific Title | VOice-guided AI Cancer Evaluation (VOICE) Study |
| Date of disclosure of the study information | 2022/11/02 |
| Last modified on | 2022/11/02 18:41:38 |
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Basic information
Public title
VOice-guided AI Cancer Evaluation (VOICE) Study
Acronym
VOICE study
Scientific Title
VOice-guided AI Cancer Evaluation (VOICE) Study
Scientific Title:Acronym
VOice-guided AI Cancer Evaluation (VOICE) Study
Region
| Japan |
Condition
Condition
Lung Cancer
Classification by specialty
| Pneumology | Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To develop a platform for rapid and simple diagnosis and disease monitoring by analyzing the voices of cancer patients with lesions in the lower respiratory tract
Basic objectives2
Others
Basic objectives -Others
To develop a platform for rapid and simple diagnosis and disease monitoring
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Developing a platform for voice-activated cancer diagnosis
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 over 18 years of age at the time of enrollment;
2. patients with histologically diagnosed or suspected cancer
3. patients with lesions in the lower respiratory tract
4. patients who have given written informed consent to participate in this study. If the patient is a minor, the consent of a surrogate (parent or legal guardian) must be obtained.
Key exclusion criteria
Patients deemed inappropriate by the principal investigator or subinvestigator
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Takafumi |
| Middle name | |
| Last name | Koyama |
Organization
National Cancer Center Hospital, Japan
Division name
Developmental Therapeutics Department
Zip code
104-0045
Address
5-1-1. Tsukiji Chuoku, Tokyo, Japan
TEL
03-3542-2511
takoyama@ncc.go.jp
Public contact
Name of contact person
| 1st name | Akiko |
| Middle name | |
| Last name | Tateishi |
Organization
National Cancer Center Hospital, Japan
Division name
Thoracic Oncology Department
Zip code
104-0045
Address
5-1-1. Tsukiji Chuoku, Tokyo, Japan
TEL
03-3542-2511
Homepage URL
atateish@ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital, Japan
Institute
Department
Personal name
Funding Source
Organization
Axe co.
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 Hospital Research Ethics Review Committee
Address
5-1-1. Tsukiji Chuoku, Tokyo, Japan
Tel
0335422511
irst@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
| 2022 | Year | 11 | Month | 02 | 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
| 2021 | Year | 06 | Month | 30 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2021 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2022 | Year | 11 | Month | 02 | Day |
Last modified on
| 2022 | Year | 11 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056267
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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