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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000001676
Receipt No. R000002024
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
Date of disclosure of the study information 2009/01/31
Last modified on 2021/10/13

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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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