UMIN-CTR Clinical Trial

Basic information
Public title	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
Acronym	Follow up study after EMR for esophageal squamous cell carcinoma
Scientific Title	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
Scientific Title:Acronym	Follow up study after EMR for esophageal squamous cell carcinoma
Region	Japan

Condition
Condition	Esophageal squamous cell carcinoma
Classification by specialty	Gastroenterology Oto-rhino-laryngology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Previous studies have reported that multiple Lugol-voiding lesions of the background esophageal mucosa are associated with a very high risk of multiple cancers in the esophagus, as well as the head and neck region. The ability to use Lugol-voiding pattern as a biomarker for the risk of second primary cancers in the esophagus and head and neck region after endoscopic mucosal resection (EMR) in patients with esophageal cancer would facilitate the early detection and treatment of metachronous multiple cancers, contribute to improved outcomes of EMR, and thereby approach a more ideal surveillance period after EMR.
Basic objectives2	Others
Basic objectives -Others	The aim of this study is 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.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The cumulative incidence of metachronous multiple cancers of the esophagus as assessed by the Lugol-voiding pattern.
Key secondary outcomes	1) The total annual number of cases of metachronous multiple cancer of the esophagus as assessed by the Lugol-voiding pattern. 2) The cumulative incidence of metachronous multiple cancers of the head and neck region as assessed by the Lugol-voiding pattern.

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	Prevention
Type of intervention	Behavior,custom
Interventions/Control_1	At study entry, patients will be instructed to abstain from smoking and drinking alcohol.
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	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 as assessed visually on Lugol chromoendoscopy immediately after EMR. (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 EMR. (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	330

Research contact person
Name of lead principal investigator	1st name Manabu Middle name Last name Muto
Organization	Kyoto University Hospital
Division name	Department of Clinical Oncology
Zip code	606-8507
Address	54 Shogoinkawaharacho, Sakyo-ku, Kyoto, 606-8507, Japan.
TEL	075-751-4592
Email	mmuto@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Chikatoshi Middle name Last name Katada
Organization	Kitasato University Hospital
Division name	Department of Gastroenterology
Zip code	252-0374
Address	1-15-1 Kitasato, Sagamihara 228-8555, Japan.
TEL	042-778-8111
Homepage URL
Email	ckatada@med.kitasato-u.ac.jp

Sponsor
Institute	Kyoto University
Institute
Department

Funding Source
Organization	Kyoto University
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	Clinical research review board of the Kitasato Institute
Address	1-15-1 Kitasato, Minami, Sagamihara, Japan.
Tel	042-778-8111
Email	rinrib@med.kitasato-u.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	2009 Year 01 Month 31 Day

Related information
URL releasing protocol	None
Publication of results	Partially published

Result
URL related to results and publications	Ongoing
Number of participants that the trial has enrolled	331
Results	Ongoing
Results date posted	2021 Year 10 Month 13 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Ongoing
Participant flow	Ongoing
Adverse events	Ongoing
Outcome measures	Ongoing
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2005 Year 05 Month 26 Day
Date of IRB	2005 Year 05 Month 26 Day
Anticipated trial start date	2005 Year 09 Month 01 Day
Last follow-up date	2025 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2009 Year 01 Month 31 Day
Last modified on	2021 Year 10 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002024

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name
2017/12/27	JEC経過観察データ固定20171227.xls

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