UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018608 |
|---|---|
| Receipt number | 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 | 2021/10/13 21:34:35 |
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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
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
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
ckatada@med.kitasato-u.ac.jp
Sponsor or person
Institute
AMED
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021331
