UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011042 |
|---|---|
| Receipt number | R000012925 |
| Scientific Title | Photodynamic diagnosis of head and neck cancer using 5-aminolevulinic acid |
| Date of disclosure of the study information | 2013/06/27 |
| Last modified on | 2015/06/29 18:00:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Photodynamic diagnosis of head and neck cancer using 5-aminolevulinic acid
Acronym
Photodynamic diagnosis of head and neck cancer
Scientific Title
Photodynamic diagnosis of head and neck cancer using 5-aminolevulinic acid
Scientific Title:Acronym
Photodynamic diagnosis of head and neck cancer
Region
| Japan |
Condition
Condition
Head and neck cancers
Classification by specialty
| Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To assess the value of fluorescence guided resection of head and neck cancers after application of 5-aminolevulinic acid.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Comparison between intensity of fluorescence and pathology of specimen
Key secondary outcomes
complications
Base
Study type
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Fluorescence endoscope after oral application of 5-aminolevulinic acid (20mg/Kg)
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with head and neck cancers or suspicious of head and neck cancer
Key exclusion criteria
Patients with Porphyria, severe liver or kidney disorders or poor general condition
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taisuke Kobayashi |
Organization
Kochi Medical School
Division name
Otolaryngology
Zip code
Address
Kohasu, Oko, Nankoku, KOCHI
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taisuke Kobayashi |
Organization
Kochi Medical School
Division name
Otolaryngology
Zip code
Address
Kohasu, Oko, Nankoku, KOCHI
TEL
088-880-2393
Homepage URL
Sponsor or person
Institute
Department of otolaryngology, Kochi Medical School
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
高知大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 06 | Month | 27 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 06 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 06 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 25 | Day |
Last modified on
| 2015 | Year | 06 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012925
