UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034761 |
|---|---|
| Receipt number | R000039642 |
| Scientific Title | A study on genetic polymorphism analysis using buccal mucosal tissue of the registered patients (UMIN000001676) |
| Date of disclosure of the study information | 2018/11/05 |
| Last modified on | 2018/11/04 16:32:32 |
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Basic information
Public title
A study on genetic polymorphism analysis using buccal mucosal tissue of the registered patients (UMIN000001676)
Acronym
Japan Esophageal Cohort study Genetic polymorphism analysis: JEC-G study
Scientific Title
A study on genetic polymorphism analysis using buccal mucosal tissue of the registered patients (UMIN000001676)
Scientific Title:Acronym
Japan Esophageal Cohort study Genetic polymorphism analysis: JEC-G study
Region
| Japan |
Condition
Condition
Esophageal squamous cell carcinoma
Classification by specialty
| Gastroenterology | Oto-rhino-laryngology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
For patients enrolled in clinical trials (UMIN000001676), we evaluate the risk of esophageal cancer and abstinence effect of smoking and drinking alcohol according to ALDH2/ADH1B/CYP2A6 gene polymorphism.
Basic objectives2
Others
Basic objectives -Others
The aim of this study is to investigate the risk of metachronous cancers and assess the period required for their development after endoscopic resection, using Lugol-voiding pattern and ALDH2/ADH1B/CYP2A6 gene polymorphism in patients with esophageal squamous cell carcinoma after endoscopic resection.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The cumulative incidence of metachronous cancers as assessed by the Lugol-voiding pattern and ALDH2/ADH1B/CYP2A6 gene polymorphism
Key secondary outcomes
The total annual number of cases of metachronous cancers as assessed by the Lugol-voiding pattern and ALDH2/ADH1B/CYP2A6 gene polymorphism
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) Newly diagnosed early squamous cell carcinoma of the esophagus.
(2) Complete endoscopic resection (ER) as assessed visually on Lugol chromoendoscopy immediately after ER.
(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 ER.
(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
331
Research contact person
Name of lead principal investigator
| 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 Japan
TEL
042-778-8111
ckatada@med.kitasato-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 Japan
TEL
042-778-8111
Homepage URL
ckatada@med.kitasato-u.ac.jp
Sponsor or person
Institute
Grant-in-Aid for Scientific Research
Institute
Department
Personal name
Funding Source
Organization
Grant-in-Aid for Scientific Research
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
Address
Tel
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
| 2018 | Year | 11 | Month | 05 | 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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 05 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 11 | Month | 05 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
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 (UMIN000001676)
Management information
Registered date
| 2018 | Year | 11 | Month | 04 | Day |
Last modified on
| 2018 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039642
