UMIN-CTR Clinical Trial

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
Email	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
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	Hokkaido University Hospital Division of Clinical Research Administration
Address	Kita 15, Nishi 7, Kita-ku, Sapporo, Hokkaido, Japan
Tel	011-706-5003
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039552