UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021817 |
|---|---|
| Receipt number | 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 13:38:23 |
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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
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
endok@med.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025155
