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

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 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

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

Value
https://center6.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