UMIN-CTR Clinical Trial

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
Email	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
Email	atateish@ncc.go.jp

Sponsor
Institute	National Cancer Center Hospital, Japan
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056267