UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001676 |
|---|---|
| Receipt number | 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 21:35:39 |
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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
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
ckatada@med.kitasato-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
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
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
Value
https://center6.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 |
