UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045903 |
|---|---|
| Receipt number | R000052044 |
| Scientific Title | The relationship between upper gastrointestinal tumors and the amount of skin carotenoids |
| Date of disclosure of the study information | 2021/10/29 |
| Last modified on | 2021/10/28 19:39:09 |
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Basic information
Public title
The relationship between upper gastrointestinal tumors and the amount of skin carotenoids
Acronym
The relationship between upper gastrointestinal tumors and the amount of skin carotenoids
Scientific Title
The relationship between upper gastrointestinal tumors and the amount of skin carotenoids
Scientific Title:Acronym
The relationship between upper gastrointestinal tumors and the amount of skin carotenoids
Region
| Japan |
Condition
Condition
Gastrointestinal disease
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the relationship between upper gastrointestinal tumors (duodenum, stomach, esophagus, pharynx, larynx) and skin carotenoid levels
Basic objectives2
Others
Basic objectives -Others
Skin carotenoid level
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Skin carotenoid level,
Key secondary outcomes
Age, gender, primary disease, medical history,family history, oral medicine history, weight, height, alcohol drinking habit, flushing, smoking, vegetable intake, fruit intake, living habits (family composition, marriage, dietary habit)
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
Patients who are visiting or hospitalized in the Department of Gastroenterology, Toranomon Hospital for upper gastrointestinal tumors (atypical epithelium or cancer of the duodenum, stomach, esophagus, pharynx, larynx).
Key exclusion criteria
1.Those who did not agree to participate in this study.
2.Those who participated in another research during the study period.
3.Those who cannot measure the skin using Vegecheck due to scratches on the measurement site of the palm.
4.Those who have undergone upper gastrointestinal surgery.
5.Those who have been hospitalized within the past month or who have had restrictions on dietary intake.
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Daisuke |
| Middle name | |
| Last name | Kikuchi |
Organization
Toranomon hospital
Division name
Department of Gastroenterology
Zip code
105-8470
Address
2-2-2, Toranomon, Minato, Tokyo
TEL
03-3588-1111
dkiku1230@gmail.com
Public contact
Name of contact person
| 1st name | Junnosuke |
| Middle name | |
| Last name | Hayasaka |
Organization
Toranomon hospital
Division name
Department of Gastroenterology
Zip code
105-8470
Address
2-2-2, Toranomon, Minato, Tokyo
TEL
03-3588-1111
Homepage URL
bandwagondane@gmail.com
Sponsor or person
Institute
Toranomon hospital
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
Kagome CO. LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Toranomon Hospital
Address
2-2-2, Toranomon, Minato, Tokyo
Tel
03-3588-1111
chiken-jim@toranomon.gr.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
2021-R05
Org. issuing International ID_1
Kagome Research Ethics Committee
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
虎の門病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 29 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 07 | Month | 07 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 07 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Prospective cohort observational study
Subject: Patients who visit our facility or are hospitalized from October 2021 to January 2022 and meet the selection criteria
Assessment: skin carotenoid level, primary disease, medical history, age, gender, family history, oral medicine history, weight, height, alcohol drinking habit, flushing, smoking, vegetable intake, fruit intake, living habits (family composition, marriage, dietary habit)
Management information
Registered date
| 2021 | Year | 10 | Month | 28 | Day |
Last modified on
| 2021 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052044
