UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034980 |
|---|---|
| Receipt number | R000039552 |
| Scientific Title | Risk assessment of metachronous squamous cell carcinoma after endoscopic resection for head and neck cancer based on the genetic polymorphisms of alcoholdehydrogenase-1B aldehydedehydrogenase-2 |
| Date of disclosure of the study information | 2018/11/23 |
| Last modified on | 2020/05/25 10:46:22 |
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Basic information
Public title
Risk assessment of metachronous squamous cell carcinoma after endoscopic resection for head and neck cancer based on the genetic polymorphisms of alcoholdehydrogenase-1B aldehydedehydrogenase-2
Acronym
Risk assessment of metachronous squamous cell carcinoma after endoscopic resection for head and neck cancer based on the genetic polymorphisms of alcoholdehydrogenase-1B aldehydedehydrogenase-2
Scientific Title
Risk assessment of metachronous squamous cell carcinoma after endoscopic resection for head and neck cancer based on the genetic polymorphisms of alcoholdehydrogenase-1B aldehydedehydrogenase-2
Scientific Title:Acronym
Risk assessment of metachronous squamous cell carcinoma after endoscopic resection for head and neck cancer based on the genetic polymorphisms of alcoholdehydrogenase-1B aldehydedehydrogenase-2
Region
| Japan |
Condition
Condition
head and neck cancer, esophageal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To assessment the risk of metachronous head and neck cancer after endoscopic resection
Basic objectives2
Others
Basic objectives -Others
To clarify the risk of metachronous head and neck cancer and esophageal cancer after endoscopic resection based on the genetic polymorphisms of alcoholdehydrogenase-1B aldehydedehydrogenase-2
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the risk of metachronous head and neck cancer after endoscopic resection
Key secondary outcomes
Base
Study type
Interventional
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
It collected the saliva in all cases.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 It is possible to take saliva.
2 Written informed consent after an enough explanation
3 Endoscopic resection was performed for head and neck cancer.
4 Squamous cell carcinoma was histologically confirmed in resected specimen.
5 Endoscopic complete resection
Key exclusion criteria
1 Surgery was added.
2 Patients who had an an operation of total laryngectomy.
3 Ineligible for participating in this study according to the principal investigators
4 Less than 20 years old
5 During pregnancy
Target sample size
220
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Shimizu |
Organization
Hokkaido University Hospital
Division name
Division of Endoscopy
Zip code
060-8648
Address
kita 14 jo, nishi 5 chome, kita-ku, Sapporo, Japan
TEL
011-716-1161
mokomokomomon@gmail.com
Public contact
Name of contact person
| 1st name | Masaki |
| Middle name | |
| Last name | Inoue |
Organization
Graduate School of Medicine and Faculty of Medicine, Hokkaido University
Division name
Department of Gastroenterology and Hepatology
Zip code
060-8648
Address
kita 14 jo, nishi 5 chome, kita-ku, Sapporo, Japan
TEL
011-716-1161
Homepage URL
mokomokomomon@gmail.com
Sponsor or person
Institute
Hokkaido University
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
Hokkaido University Hospital Division of Clinical Research Administration
Address
Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido, Japan
Tel
011-706-5003
shomu@med.hokudai.ac.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
| 2018 | Year | 11 | Month | 23 | 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
200
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
Completed
Date of protocol fixation
| 2018 | Year | 10 | Month | 02 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 02 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 04 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 11 | Month | 23 | Day |
Last modified on
| 2020 | Year | 05 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039552
