UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032786 |
|---|---|
| Receipt number | R000037171 |
| Scientific Title | Implementation of personalized therapy for esophageal cancer |
| Date of disclosure of the study information | 2018/06/01 |
| Last modified on | 2023/06/10 19:07:01 |
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Basic information
Public title
Implementation of personalized therapy for esophageal cancer
Acronym
Personalized therapy for esophageal cancer
Scientific Title
Implementation of personalized therapy for esophageal cancer
Scientific Title:Acronym
Personalized therapy for esophageal cancer
Region
| Japan |
Condition
Condition
Esophageal cancer
Classification by specialty
| Medicine in general | Gastroenterology | Surgery in general |
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
The purposes of this clinical trial for achievement of a personalized therapy for esophageal cancer patients are 1) to investigate factors related to antitumor response using endoscopic biopsy from a tumor and normal mucosa before and after initial chemo(radio)therapy, and 2) to examine risk factors of adverse events related to initial chemo(radio)therapy using an extracted blood serum of esophageal cancer patient.
Basic objectives2
Others
Basic objectives -Others
Analysis using human tissue for personalized therapy
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Prediction of response to a preoperative chemotherapy based on an expression analysis of mRNA and protein extracted from biopsy specimen prior to treatment untie 4 weeks after chemotherapy
Key secondary outcomes
Prediction of severe adverse events based on expression analysis of IL2, IL6, IL12 and polymorphism of CYP2E1 in the serum prior to treatment
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients with esophageal cancer examined in Department of Esophageal Surgery, Breast and Thyroid Surgery
2. All histological types and stages are applicable.
3. Limitation of age is over 18 year-old
4. Main organs (brain, heart, lung, liver, kidney) functions are retained.
5. Clinical trial consent is obtained in writing.
Key exclusion criteria
1. Patients who can not undergo upper gastrointestinal endoscopy
2. Patients from whom clinical trial consent is mot obtained in writing
3. Patients who investigators of this clinical trial assess not applicable in terms of safety
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Seiya |
| Middle name | |
| Last name | Inoue |
Organization
Institute of Biomedical Sciences
Tokushima University Graduate School
Division name
Department of Thoracic, Endocrine Surgery and Oncology
Zip code
770-8503
Address
3-18-15 Kutramoto-cho Tokushima
TEL
0886337143
tangoku@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Seiya |
| Middle name | |
| Last name | Inoue |
Organization
Institute of Biomedical Sciences Tokushima University Graduate School
Division name
Department of Thoracic, Endocrine Surgery and Oncology
Zip code
770-8503
Address
3-18-15 Kutramoto-cho Tokushima
TEL
0886337143
Homepage URL
http://www.tksbizan.com/
inoue.seiya@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Thoracic, Endocrine Surgery and Oncology Institute of Biomedical Sciences Tokushima University Graduate School
Institute
Department
Personal name
Funding Source
Organization
Institute of Biomedical Sciences Tokushima University Graduate School
Organization
Division
Category of Funding Organization
Government offices of other countries
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Biomedical Sciences Tokushima University Graduate School
Address
3-18-15 Kutramoto-cho Tokushima
Tel
088-633-7143
inoue.seiya@tokushima-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
| 2018 | Year | 06 | Month | 01 | 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 | 06 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not appropriate
Management information
Registered date
| 2018 | Year | 05 | Month | 30 | Day |
Last modified on
| 2023 | Year | 06 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037171
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
