UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A performance evaluation of OncAlertTM POC Test, an in vitro diagnostic for head and neck cancer
Title of the study (Brief title)	Evaluation of OncAlertTM POC Test
Region	Japan

Condition
Condition	Head and neck cancer
Classification by specialty	Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Oral cancer is a cancer that can be easily detected by visual inspection or palpation. In Japan, however, about a half of the patients are actually detected in an advanced stage III or IV.2 More than 90% of oral cancer is squamous cell cancer2 that is estimated to be detectable by OncAlertTM in an early stage.3 When using 　OncAlertTM LAB Assay, predicted ranges of sensitivity and specificity for oral cancer are reported to be 87% and 74%, respectively;4 thus, it is expected to contribute to the early detection of oral cancer. However, the evaluation of OncAlertTM POC Test has not been reported so far.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Evaluation of the sensitivity and specificity of OncAlertTM POC Test　before treatment
Key secondary outcomes	Evaluation of the sensitivity and specificity of OncAlertTM POC Test by original site of cancer　before treatment

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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with head and neck squamous cell carcinoma
Key exclusion criteria	Patients who do not want to participate this study
Target sample size	40

Research contact person
Name of lead principal investigator	Tomokazu Yoshizaki
Organization	Kanazawa University Hospital
Division name	Division of Otolaryngology
Address	13-1 Takara-machi, Kanazawa, Ishikawa
TEL	076-265-2413
Email	tomoy@med.kanazawa-u.ac.jp

Public contact
Name of contact person	Kazuhira Endo
Organization	Kanazawa University Hospital
Division name	Division of Otolaryngology
Address	13-1 Takara-machi, Kanazawa, Ishikawa
TEL	076-265-2413
Homepage URL
Email	endok@med.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa University
Institute
Department

Funding Source
Organization	Japan BCG Laboratory
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2017 Year 04 Month 01 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2016 Year 04 Month 01 Day
Anticipated trial start date	2018 Year 03 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	This study was canceled due to the no supply of the OnecAlert TM kit
Other related information	None

Management information
Registered date	2016 Year 04 Month 07 Day
Last modified on	2018 Year 07 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025155