UMIN-CTR Clinical Trial

Public title

A study on genetic polymorphism analysis using buccal mucosal tissue of the registered patients (UMIN000001676)

Acronym

Japan Esophageal Cohort study Genetic polymorphism analysis: JEC-G study

Scientific Title

A study on genetic polymorphism analysis using buccal mucosal tissue of the registered patients (UMIN000001676)

Scientific Title:Acronym

Japan Esophageal Cohort study Genetic polymorphism analysis: JEC-G study

Region

Japan

Condition

Esophageal squamous cell carcinoma

Classification by specialty

Gastroenterology

Oto-rhino-laryngology

Classification by malignancy

Malignancy

Genomic information

YES

Narrative objectives1

For patients enrolled in clinical trials (UMIN000001676), we evaluate the risk of esophageal cancer and abstinence effect of smoking and drinking alcohol according to ALDH2/ADH1B/CYP2A6 gene polymorphism.

Basic objectives2

Others

Basic objectives -Others

The aim of this study is to investigate the risk of metachronous cancers and assess the period required for their development after endoscopic resection, using Lugol-voiding pattern and ALDH2/ADH1B/CYP2A6 gene polymorphism in patients with esophageal squamous cell carcinoma after endoscopic resection.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The cumulative incidence of metachronous cancers as assessed by the Lugol-voiding pattern and ALDH2/ADH1B/CYP2A6 gene polymorphism

Key secondary outcomes

The total annual number of cases of metachronous cancers as assessed by the Lugol-voiding pattern and ALDH2/ADH1B/CYP2A6 gene polymorphism

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

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

Age-lower limit

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

(1) Newly diagnosed early squamous cell carcinoma of the esophagus.
(2) Complete endoscopic resection (ER) as assessed visually on Lugol chromoendoscopy immediately after ER.
(3) A diagnosis of squamous cell carcinoma on histopathological examination of the resected specimen.
(4) Vertical margins of the resected specimen are confirmed to be tumor-negative.
(5) Tumor invasion is limited to the mucosa on histopathological examination of the resected specimen, and no additional treatment (surgical resection, radiotherapy, chemotherapy, etc.) is performed immediately after ER.
(6) No active head or neck cancers.
(7) The investigator judges that patient can be observed for at least 2 years.
(8) Written informed consent is obtained from the patient.

Key exclusion criteria

(1) A history of chemotherapy for any other cancers or a history of surgical treatment or radiotherapy for head and neck cancers.
(2) A history of iodine allergy.
(3) Patients whom the investigator considers unsuitable as subjects for this study.

Target sample size

331

Name of lead principal investigator

1st name
Middle name
Last name	Chikatoshi Katada

Organization

Kitasato University School of Medicine

Division name

Department of Gastroenterology

Zip code

Address

1-15-1 Kitasato Minami Sagamihara Kanagawa Japan

TEL

042-778-8111

Email

ckatada@med.kitasato-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Chikatoshi Katada

Organization

Kitasato University School of Medicine

Division name

Department of Gastroenterology

Zip code

Address

1-15-1 Kitasato Minami Sagamihara Kanagawa Japan

TEL

042-778-8111

Homepage URL

Email

ckatada@med.kitasato-u.ac.jp

Institute

Grant-in-Aid for Scientific Research

Institute

Department

Personal name

Organization

Grant-in-Aid for Scientific Research

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2018

Year

11

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Enrolling by invitation

Date of protocol fixation

2018

Year

05

Month

09

Day

Date of IRB

Anticipated trial start date

2018

Year

11

Month

05

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Multicenter cohort study to investigate the risk of metachronous multiple cancers and assess the period required for their development after EMR, using Lugol-voiding pattern as a biomarker in patients with esophageal squamous cell carcinoma (UMIN000001676)

Registered date

2018

Year

11

Month

04

Day

Last modified on

2018

Year

11

Month

04

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039642