UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051870 |
|---|---|
| Receipt number | R000059172 |
| Scientific Title | Health assessment using percutaneous optical imaging in patients with esophageal cancer and esophagogastric junction cancer: a prospective observational study |
| Date of disclosure of the study information | 2023/08/09 |
| Last modified on | 2023/08/09 12:32:25 |
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Basic information
Public title
Health assessment using percutaneous optical imaging in patients with esophageal cancer and esophagogastric junction cancer: a prospective observational study
Acronym
Health assessment using percutaneous optical imaging in patients with esophageal cancer and esophagogastric junction cancer: a prospective observational study
Scientific Title
Health assessment using percutaneous optical imaging in patients with esophageal cancer and esophagogastric junction cancer: a prospective observational study
Scientific Title:Acronym
Health assessment using percutaneous optical imaging in patients with esophageal cancer and esophagogastric junction cancer: a prospective observational study
Region
| Japan |
Condition
Condition
esophageal cancer and esophagogastric junction cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective is to construct a highly accurate model for predicting a patient's general condition by analyzing the correlation between the features derived from RGB values obtained by photographing the patient's face and tongue with a camera and the clinical data.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between the features derived from RGB values obtained by percutaneous optical imaging and QOL scores
Key secondary outcomes
Correlation between the features derived from RGB values obtained by percutaneous optical imaging and the clinical data such as vital signs, weight, blood data, and clinical 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patients diagnosed with esophageal cancer or esophagogastric junction cancer.
2) Patients who are 20 years of age or older at the time of consent.
3) Patients who have been fully informed of the study and who have given written consent of their own will.
Key exclusion criteria
Patients who are deemed by the investigator or subinvestigator to be unsuitable for this study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Matsubara |
| Middle name | |
| Last name | Hisahiro |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Frontier Surgery
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
81-43-226-2110
matsuhm@faculty.chiba-u.jp
Public contact
Name of contact person
| 1st name | Murakami |
| Middle name | |
| Last name | Kentaro |
Organization
Graduate School of Medicine, Chiba University
Division name
Department of Frontier Surgery
Zip code
260-8670
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
TEL
81-43-226-2110
Homepage URL
murakami2621@chiba-u.jp
Sponsor or person
Institute
Graduate School of Medicine, Chiba University
Institute
Department
Personal name
Kentaro Murakami
Funding Source
Organization
No funding source
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
Department of Frontier Surgery, Graduate School of Medicine, Chiba University
Address
1-8-1 Inohana, Chuo-ku, Chiba, Japan
Tel
81-43-226-2462
inohana-rinri@chiba-u.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
| 2023 | Year | 08 | Month | 09 | 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
| 2022 | Year | 03 | Month | 05 | Day |
Date of IRB
| 2022 | Year | 05 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 08 | Month | 09 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Facial and tongue imaging will be performed during the routine examination for esophageal and esophagogastric junction cancer. Quality of life scores are also collected at this time.
Management information
Registered date
| 2023 | Year | 08 | Month | 09 | Day |
Last modified on
| 2023 | Year | 08 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000059172
| 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 |
