UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040399 |
|---|---|
| Receipt number | R000044465 |
| Scientific Title | Analysis of risk factors for diagnosis of esophageal cancer in Japan |
| Date of disclosure of the study information | 2020/05/19 |
| Last modified on | 2024/03/22 11:59:31 |
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Basic information
Public title
Analysis of risk factors for diagnosis of esophageal cancer
Acronym
Analysis of risk factors of esophageal cancer
Scientific Title
Analysis of risk factors for diagnosis of esophageal cancer in Japan
Scientific Title:Acronym
Analysis of risk factors of esophageal cancer in Japan
Region
| Japan |
Condition
Condition
Esophagial cancer
Classification by specialty
| Gastroenterology | Gastrointestinal surgery | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Analysis of risk factors for diagnosis of esophageal cancer in Japan
Basic objectives2
Others
Basic objectives -Others
Analyze histological differences between patients with and without risk factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To assess the histological differences in esophageal cancer from January 1, 2011 to December 31, 2019 between patients with and without risk factors.
Key secondary outcomes
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Esophageal cancer patients treated at the Kawasaki Medical School General Medical Center and Kawasaki Medical School Hospital from January 1, 2011 to December 31, 2019
Key exclusion criteria
Other than esophageal squamous cell carcinoma
Target sample size
600
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Nakamura |
Organization
Kawasaki medical school general medical center
Division name
Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine, Kawasaki Medical School
Zip code
700-8505
Address
2-6-1 Nakasange, Kita-ku, Okayama City
TEL
086-225-2111
j.nakamura@med.kawasaki-m.ac.jp
Public contact
Name of contact person
| 1st name | Jun |
| Middle name | |
| Last name | Nakamura |
Organization
Kawasaki medical school general medical center
Division name
Division of Endoscopy and Ultrasonography, Department of Clinical Pathology and Laboratory Medicine
Zip code
700-8505
Address
2-6-1 Nakasange, Kita-ku, Okayama City
TEL
086-225-2111
Homepage URL
j.nakamura@med.kawasaki-m.ac.jp
Sponsor or person
Institute
Kawasaki medical school
Institute
Department
Personal name
Funding Source
Organization
Kawasaki medical school
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kawasaki medical school
Address
577,matushima,kurashiki city
Tel
086-462-1111
kmsrec@med.kawasaki-m.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
| 2020 | Year | 05 | Month | 19 | Day |
Related information
URL releasing protocol
Currently not open to the public
Publication of results
Published
Result
URL related to results and publications
https://bmcgastroenterol.biomedcentral.com/articles/10.1186/s12876-022-02399-3
Number of participants that the trial has enrolled
469
Results
Multivariate Cox regression analysis identified sex, TNM classification, and subjective symptoms as independent risk factors for overall survival. In the symptomatic group, the mean time from symptom onset to diagnosis was 2.4+-4.3 months. The incidence of subjective symptoms differed by clinical stage, and the prognosis of patients with swallowing-related symptoms was significantly worse than that of patients with other symptoms.
Results date posted
| 2022 | Year | 05 | Month | 16 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 06 | Month | 28 | Day |
Baseline Characteristics
From April 2011 to December 2019, 469 patients diagnosed with esophageal cancer at Kawasaki Medical School General Medical Center and Kawasaki Medical School Hospital, and endoscopy at the same facility during the same period 400 control cases matched with receiving age.
Participant flow
The control group was a medical examination examinee who underwent endoscopy at Kawasaki Medical School General Hospital and Kawasaki Medical School Hospital, and the case group and sex age were matched and randomly selected as much as possible.
Adverse events
none
Outcome measures
To assess whether background disorders (hypertension, dyslipidemia, diabetes, history of multi-organ cancer) are involved in the development or development of esophageal cancer.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 06 | Day |
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Differences in histology was evaluated by between esophageal cancer patients treated at Kawasaki Medical School General Medical Center and Kawasaki Medical School Hospital and sex- and age-matched controls who underwent upper GI endoscopy.
Management information
Registered date
| 2020 | Year | 05 | Month | 14 | Day |
Last modified on
| 2024 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044465
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