UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019852 |
|---|---|
| Receipt number | R000022932 |
| Scientific Title | Evaluation of the risk of metachronous squamous cell carcinoma of the esophagus and the head and neck after endoscopic resection for squamous cell carcinoma of the esophagus according to genetic polymorphisms of alcohol dehydrogense-1B and aldehyde dehydrogenase-2. |
| Date of disclosure of the study information | 2015/11/19 |
| Last modified on | 2020/05/22 21:55:32 |
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Basic information
Public title
Evaluation of the risk of metachronous squamous cell carcinoma of the esophagus and the head and neck after endoscopic resection for squamous cell carcinoma of the esophagus according to genetic polymorphisms of alcohol dehydrogense-1B and aldehyde dehydrogenase-2.
Acronym
Evaluation of the risk of metachronous squamous cell carcinoma of the esophagus and the head and neck after endoscopic resection for squamous cell carcinoma of the esophagus according to genetic polymorphisms of ADH1B and ALDH2.
Scientific Title
Evaluation of the risk of metachronous squamous cell carcinoma of the esophagus and the head and neck after endoscopic resection for squamous cell carcinoma of the esophagus according to genetic polymorphisms of alcohol dehydrogense-1B and aldehyde dehydrogenase-2.
Scientific Title:Acronym
Evaluation of the risk of metachronous squamous cell carcinoma of the esophagus and the head and neck after endoscopic resection for squamous cell carcinoma of the esophagus according to genetic polymorphisms of ADH1B and ALDH2.
Region
| Japan |
Condition
Condition
squamous cell carcinoma of the esophagus and the head and neck
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the risk of metachronous squamous cell carcinoma of the esophagus and the head and neck after endoscopic resection for squamous cell carcinoma of the esophagus according to genetic polymorphisms of alcohol dehydrogense-1B and aldehyde dehydrogenase-2.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of metachronous squamous cell carcinoma of the esophagus and the head and neck according to genetic polymorphisms of alcohol dehydrogense-1B and aldehyde dehydrogenase-2.
Key secondary outcomes
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
Diagnosis
Type of intervention
| Other |
Interventions/Control_1
It collected the saliva in all cases.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 It is possible to take a saliva.
2 Written informed consent was obtained from all patients.
Key exclusion criteria
1 Surgery was added.
2 Officer has determined to be inappropriate.
3 Less than 20 years old.
4 During pregnancy.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Shimizu |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
060-8638
Address
kita 14 jyou nishi 5 chome, kitaku, Sapporo
TEL
011-716-1161
abiko1982@gmail.com
Public contact
Name of contact person
| 1st name | Satoshi |
| Middle name | |
| Last name | Abiko |
Organization
Hokkaido University Graduate School of Medicine
Division name
Department of Gastroenterology
Zip code
060-8638
Address
kita 14 jyou nishi 5 chome, kitaku, Sapporo
TEL
011-716-1161
Homepage URL
abiko1982@gmail.com
Sponsor or person
Institute
Hokkaido University Graduate School of Medicine
Institute
Department
Personal name
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
Hokkaido University Graduate School of Medicine
Address
kita 14 jyou nishi 5 chome, kitaku, Sapporo
Tel
011-716-1161
abiko1982@gmail.com
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 | 11 | Month | 19 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/29423536/?from_term=abiko+S+hokudai&from_pos=2
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/29423536/?from_term=abiko+S+hokudai&from_pos=2
Number of participants that the trial has enrolled
158
Results
Results: Multivariate analyses revealed that inactive heterozygous ALDH2 [hazard ratio (HR) 2.25] and alcohol consumption after ER (HR 1.94) were independently associated with the risk of developing secondary SCC. Moreover, inactive heterozygous ALDH2 (HR 4.39) and alcohol consumption after the ER (HR 2.82) were independently associated with the risk of a third SCC.
Results date posted
| 2020 | Year | 05 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Background: Metachronous multiple squamous cell carcinoma (SCC) of the esophagus and the head and neck is commonly observed in patients who have previously undergone endoscopic resection (ER) for SCC of the esophagus (ESCC). We evaluated the risk for developing metachronous SCC following ER for ESCC based on the genetic polymorphisms for alcohol dehydrogenase-1B (ADH1B) and aldehyde dehydrogenase-2 (ALDH2) as well as the alcohol consumption and smoking habits.
Participant flow
Methods: We studied 158 patients who underwent ER for ESCC (median follow-up 80 months). Genotyping of ADH1B/ALDH2 was performed using saliva sampling. The alcohol consumption and smoking histories of the patients before and after the ER were documented.
Adverse events
no
Outcome measures
Results: Multivariate analyses revealed that inactive heterozygous ALDH2 [hazard ratio (HR) 2.25] and alcohol consumption after ER (HR 1.94) were independently associated with the risk of developing secondary SCC. Moreover, inactive heterozygous ALDH2 (HR 4.39) and alcohol consumption after the ER (HR 2.82) were independently associated with the risk of a third SCC. We analyzed 110 patients who had a history of moderate or heavy alcohol consumption before the ER. The 3-year cumulative incidence rates of secondary SCC in the temperance (n = 65) and non-temperance groups (n = 45) were 14.0 and 42.1% (p = 0.0002). Further, the 5-year cumulative incidence rates of a third SCC in the temperance and non-temperance groups were 0 and 15.6% (p = 0.0011), respectively. In addition, the 7-year cumulative incidence rates of a fourth SCC in the temperance and non-temperance groups were 0 and 15.3% (p = 0.0015), respectively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2015 | Year | 11 | Month | 19 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Exploratory studies using new specimens
Management information
Registered date
| 2015 | Year | 11 | Month | 18 | Day |
Last modified on
| 2020 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022932
