UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043963 |
|---|---|
| Receipt number | R000046465 |
| Scientific Title | An exploratory study on the association between squamous cell carcinoma occurrence and upper gastrointestinal microbiota in patients with laryngopharyngeal cancer |
| Date of disclosure of the study information | 2021/04/18 |
| Last modified on | 2023/04/20 12:57:55 |
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Basic information
Public title
An exploratory study on the association between squamous cell carcinoma occurrence and upper gastrointestinal microbiota in patients with laryngopharyngeal cancer
Acronym
An exploratory study on the association between squamous cell carcinoma occurrence and upper gastrointestinal microbiota in patients with laryngopharyngeal cancer
Scientific Title
An exploratory study on the association between squamous cell carcinoma occurrence and upper gastrointestinal microbiota in patients with laryngopharyngeal cancer
Scientific Title:Acronym
An exploratory study on the association between squamous cell carcinoma occurrence and upper gastrointestinal microbiota in patients with laryngopharyngeal cancer
Region
| Japan |
Condition
Condition
Laryngopharyngeal cancer
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To compare the microbial profiles between the patients with laryngopharyngeal cancer and healthy subjects
Basic objectives2
Others
Basic objectives -Others
To elucidate pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Microbial profile between the patients with laryngopharyngeal cancer and healthy subjects
1) Relative abundance at the level of phylum/genus/OTU level
2) Alfa-diversity [Shannon index, Chao1 index, ACE, Number of observed OTUs]
3) Beta-diversity [weighted and unweighted UniFrac distance-based analysis]
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients with a current or past history of laryngopharyngeal cancer and healthy subjects
Key exclusion criteria
1.Patients whom the principal investigator determined to be inappropriate to participate in the study
2. Patients under the age of 20
3. Patients who are pregnant
4. Patients who underwent antibiotic treatment within a month
5. Patients who took proton pump inhibitors within a month
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Hara |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
105-8471
Address
3-19-18, Nishishinbashi, Minato-ku, Tokyo
TEL
0334331111
yukohara0526@gmail.com
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Hara |
Organization
The Jikei University School of Medicine
Division name
Department of Endoscopy
Zip code
105-8471
Address
3-19-18, Nishishinbashi, Minato-ku, Tokyo
TEL
0334331111
Homepage URL
yukohara0526@yahoo.co.jp
Sponsor or person
Institute
The Jikei University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Own resources
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
RIKEN
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Jikei University School of Medicine
Address
Department of Endoscopy
Tel
0334331111
yukohara0526@yahoo.co.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
| 2021 | Year | 04 | Month | 18 | Day |
Related information
URL releasing protocol
Testing ongoing
Publication of results
Unpublished
Result
URL related to results and publications
Testing ongoing
Number of participants that the trial has enrolled
10
Results
Testing ongoing
Results date posted
| 2023 | Year | 04 | Month | 20 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Testing ongoing
Participant flow
Testing ongoing
Adverse events
Testing ongoing
Outcome measures
Testing ongoing
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 03 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 12 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Not applicable
Management information
Registered date
| 2021 | Year | 04 | Month | 18 | Day |
Last modified on
| 2023 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046465
| 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 |
