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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000018608
Receipt No. R000021331
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
Date of disclosure of the study information 2015/08/10
Last modified on 2015/08/09

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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

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
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) 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
Middle name
Last name Manabu Muto
Organization Kyoto University Graduate School of Medicine
Division name Department of Therapeutic Oncology
Zip code
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
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, 252-0375, Japan
TEL 042-778-8111
Homepage URL
Email ckatada@med.kitasato-u.ac.jp

Sponsor
Institute Kitasato University School of Medicine, Department of Gastroenterology
Institute
Department

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
Address
Tel
Email

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
Anticipated trial start date
2015 Year 08 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 08 Month 09 Day
Last modified on
2015 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021331

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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