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Recruitment status Terminated
Unique ID issued by UMIN UMIN000021817
Receipt No. R000025155
Scientific Title A performance evaluation of OncAlertTM POC Test, an in vitro diagnostic for head and neck cancer
Date of disclosure of the study information 2017/04/01
Last modified on 2018/07/12

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Basic information
Public title A performance evaluation of OncAlertTM POC Test, an in vitro diagnostic for head and neck cancer
Acronym Evaluation of OncAlertTM POC Test
Scientific Title A performance evaluation of OncAlertTM POC Test, an in vitro diagnostic for head and neck cancer
Scientific Title:Acronym 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
1st name
Middle name
Last name Tomokazu Yoshizaki
Organization Kanazawa University Hospital
Division name Division of Otolaryngology
Zip code
Address 13-1 Takara-machi, Kanazawa, Ishikawa
TEL 076-265-2413
Email tomoy@med.kanazawa-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhira Endo
Organization Kanazawa University Hospital
Division name Division of Otolaryngology
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

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 This study was canceled due to the no supply of the OnecAlert TM kit
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 Terminated
Date of protocol fixation
2016 Year 04 Month 01 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000025155

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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