UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056557 |
|---|---|
| Receipt number | R000064624 |
| Scientific Title | Esophageal squamous cell carcinoma related gene analysis using genome analysis and exploration of biomarkers related to synchronous and metachronous cancers in other organs and prognosis prediction |
| Date of disclosure of the study information | 2024/12/25 |
| Last modified on | 2024/12/25 01:53:04 |
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Basic information
Public title
Esophageal squamous cell carcinoma related gene analysis using genome analysis and exploration of biomarkers related to synchronous and metachronous cancers in other organs and prognosis prediction
Acronym
Esophageal squamous cell carcinoma related gene analysis using genome analysis and exploration of biomarkers related to synchronous and metachronous cancers in other organs and prognosis prediction
Scientific Title
Esophageal squamous cell carcinoma related gene analysis using genome analysis and exploration of biomarkers related to synchronous and metachronous cancers in other organs and prognosis prediction
Scientific Title:Acronym
Esophageal squamous cell carcinoma related gene analysis using genome analysis and exploration of biomarkers related to synchronous and metachronous cancers in other organs and prognosis prediction
Region
| Japan |
Condition
Condition
Esophageal squamous cell carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Esophageal squamous cell carcinoma is not only caused by drinking and smoking but also by genetic factors such as polymorphisms in alcohol-metabolizing enzyme genes. This study used genomic analysis of potential risk factors to investigate the relationship between esophageal cancer and metachronous second cancers in different organs.
Basic objectives2
Others
Basic objectives -Others
Genome analysis uses signature analysis to consider risk factors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Analysis of risk factors and associated mutation signatures in superficial oesophageal squamous cell carcinoma.
Key secondary outcomes
1. Analysis of metachronous second cancers in other organs and related mutation signatures in superficial esophageal squamous cell carcinoma
2. Analysis of mutation signatures by stage in esophageal squamous cell carcinoma
3. Analysis of mutation signatures that contribute to carcinogenesis in high-risk groups with esophageal squamous cell carcinoma
4. Analysis of mutation signatures associated with recurrence and prognosis in esophageal squamous cell carcinoma
5. AI-integrated analysis of genomic factors, including AI analysis of endoscopic images
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients aged 20 years or over
2. Patients diagnosed with squamous cell carcinoma of the esophagus at our hospital
3. Patients who have consented to participate in this study by signing the consent form.
Key exclusion criteria
1. Patients who did not give consent to participate in this study
2. Patients with severe complications (heart failure, renal failure, hepatic failure, respiratory failure)
3. Patients judged to be unsuitable for participation in this study for other reasons.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | Naito |
Organization
Tokyo Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
160-0023
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-3342-6111
sakiko-n@tokyo-med.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Naito |
Organization
Tokyo Medical University
Division name
Department of Gastroenterology and Hepatology
Zip code
160-0023
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan
TEL
03-3342-6111
Homepage URL
sakiko-n@tokyo-med.ac.jp
Sponsor or person
Institute
Tokyo Medical University
Institute
Department
Personal name
Funding Source
Organization
Tokyo Medical University
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
Tokyo Medical University Institutional Review Board
Address
6-7-1, Nishishinjuku, Shinjuku-ku, Tokyo, Japan
Tel
03-3342-6111
IRB@tokyo-med.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
| 2024 | Year | 12 | Month | 25 | 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
| 2024 | Year | 04 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 04 | Month | 14 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Empirical research
Management information
Registered date
| 2024 | Year | 12 | Month | 25 | Day |
Last modified on
| 2024 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064624
