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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034980
Receipt No. 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 2018/11/23

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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 170

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Shimizu
Organization Hokkaido University Hospital
Division name Division of Endoscopy
Zip code
Address kita 14 jo, nishi 5 chome, kita-ku, Sapporo, Japan
TEL 011-716-1161
Email mokomokomomon@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Inoue
Organization Graduate School of Medicine and Faculty of Medicine, Hokkaido University
Division name Department of Gastroenterology and Hepatology
Zip code
Address kita 14 jo, nishi 5 chome, kita-ku, Sapporo, Japan
TEL 011-716-1161
Homepage URL
Email mokomokomomon@gmail.com

Sponsor
Institute Hokkaido University
Institute
Department

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
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
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
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 Enrolling by invitation
Date of protocol fixation
2018 Year 10 Month 02 Day
Date of IRB
Anticipated trial start date
2018 Year 10 Month 02 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
2018 Year 11 Month 23 Day
Last modified on
2018 Year 11 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039552

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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