UMIN-CTR Clinical Trial

Basic information
Public title	A Multicenter, Prospective, Cohort Study Examining the Incidence of Metachronous Cancer in Other Organs According to the Grade of Lugol-voiding lesion (LVL) after Curative Endoscopic Resection of Early Esophageal Cancer
Acronym	Japan Esophageal Cohort study - 2 (JEC-2)
Scientific Title	A Multicenter, Prospective, Cohort Study Examining the Incidence of Metachronous Cancer in Other Organs According to the Grade of Lugol-voiding lesion (LVL) after Curative Endoscopic Resection of Early Esophageal Cancer
Scientific Title:Acronym	Japan Esophageal Cohort study - 2 (JEC-2)
Region	Japan

Condition
Condition	Esophageal squamous cell carcinoma
Classification by specialty	Medicine in general Gastroenterology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Squamous-cell carcinoma of the esophagus is known to be often associated with metachronous cancer in other organs. This is an important issue related to outcomes in patients who undergo endoscopic resection expected to cure esophageal cancer. The JEC-1 study, a previous exploratory study, found that patients with multiple LVL (Grade C of the JEC-1 study) had a high incidence of metachronous cancer in other organs. We planned a prospective cohort study to verify whether patients with Grade C multiple LVL have an increased incidence of metachronous cancer in other organs.
Basic objectives2	Others
Basic objectives -Others	We planned a prospective cohort study to verify whether patients with Grade C multiple LVL have an increased incidence of metachronous cancer in other organs. The analyses will be conducted after completing follow-up observations for 2, 5, and 10 years after enrollment of the last patient.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	The cumulative incidence of metachronous cancers in other organs according to the grade of LVL
Key secondary outcomes	Secondary Endpoints 1) The total numbers of metachronous cancers arising in other organs per person-year according to the grade of LVL 2) The cumulative incidences of head and neck cancer and of gastric cancer according to the grade of LVL 3) The total numbers of head and neck cancers and of gastric cancers per person-year according to the grade of LVL 4) The cumulative incidences of metachronous cancers in other organs in patients who successfully quit drinking alcohol and those who did not 5) The cumulative incidences of metachronous cancers in other organs in patients who successfully quit smoking and those who did not 6) The cumulative incidences of metachronous cancer in other organs in patients who received initial treatment for esophageal cancer and patients with a history of previous treatment 7) The total numbers of metachronous cancers in other organs per person-year in patients who received initial treatment for esophageal cancer and patients with a history of previous treatment Other Analyses 1) Investigatory analysis of risk factors other than the grade of LVL for the development of metachronous cancer in other organs 2) Analysis of outcomes in enrolled patients (as compared with outcomes in the previous JEC-1 study)

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Patients undergoing EMR or ESD for esophageal cancer (initially treated cases or previously treated cases) 2) Complete endoscopic resection is judged to be feasible. 3) A histopathological diagnosis of esophageal squamous cell carcinoma on examination of resected specimens 4) Vertical margins confirmed to be negative on examination of resected specimens 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 or ESD. 6) The attending physician judges that 10 or more years of follow-up observations are possible. 7) Written informed consent is obtained directly from the patient.
Key exclusion criteria	1) Registration in the JEC-1 study 2) A history of chemotherapy (including molecular targeted therapies) 3) A history of radiotherapy or surgical resection for head and neck cancer or esophageal cancer 4) Active double cancers in other organs (However, intramucosal cancers of other organs are not regarded to be active cancers in other organs.) 5) An allergy to iodine 6) Patients considered by their attending physicians to be unsuitable for enrollment in this study
Target sample size	385

Research contact person
Name of lead principal investigator	1st name Manabu Middle name Last name Muto
Organization	Kyoto University Graduate School of Medicine
Division name	Department of Therapeutic Oncology
Zip code	606-8507
Address	54 Kawaharacho, Shogoin, Sakyo-ku, Kyoto 606-8507, Japan
TEL	075-751-4319
Email	mmuto@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person	1st name Chikatoshi Middle name Last name Katada
Organization	Kitasato University School of Medicine
Division name	Department of Gastroenterology
Zip code	252-0374
Address	1-15-1 Kitasato, Minami, Sagamihara, Kanagawa, 252-0375, Japan
TEL	042-778-8111
Homepage URL
Email	ckatada@med.kitasato-u.ac.jp

Sponsor
Institute	AMED
Institute
Department

Funding Source
Organization	AMED
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2015 Year 08 Month 10 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
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	Open public recruiting
Date of protocol fixation	2015 Year 07 Month 31 Day
Date of IRB	2015 Year 07 Month 31 Day
Anticipated trial start date	2015 Year 08 Month 11 Day
Last follow-up date	2024 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	None

Management information
Registered date	2015 Year 08 Month 09 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/icdr_e/ctr_view.cgi?recptno=R000021331