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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000047694
Receipt No. R000054375
Scientific Title Salivary oral microflora and its metabolites involved in esophageal cancer recurrence and head and neck cancer duplication.
Date of disclosure of the study information 2022/05/09
Last modified on 2022/05/09

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Basic information
Public title Salivary oral microflora and its metabolites involved in esophageal cancer recurrence and head and neck cancer duplication.
Acronym Salivary oral microflora and its metabolites involved in esophageal cancer recurrence and head and neck cancer duplication.
Scientific Title Salivary oral microflora and its metabolites involved in esophageal cancer recurrence and head and neck cancer duplication.
Scientific Title:Acronym Salivary oral microflora and its metabolites involved in esophageal cancer recurrence and head and neck cancer duplication.
Region
Japan

Condition
Condition Esophageal cancer
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the involvement of oral microbiota in esophageal cancer recurrence and head and neck cancer duplication.
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Differences in oral flora and acetaldehyde concentration in saliva among three groups of patients after endoscopic treatment for esophageal cancer: (1) no recurrence group, (2) recurrence group, and (3) group with overlapping head and neck cancer.
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
20 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Three groups of patients after endoscopic treatment for esophageal cancer: (1) no recurrence group, (2) recurrence group, and (3) group with overlapping head and neck cancer
Key exclusion criteria (1)Patients with a history of prior esophageal cancer treatment (chemoradiotherapy or surgery) other than endoscopic treatment
(2)Patients with a history of chemoradiotherapy or surgery for esophageal cancer
(3) Patients with difficulty in saliva collection
(4) Pregnant women or patients who may become pregnant
(5) Cases in which the patient is under 20 years old
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yasuhito
Middle name
Last name Tanaka
Organization Kumamoto University Hospital
Division name Gastroenterology and Hepatology
Zip code 860-8556
Address 1-1-1 Honjo, Chuo-ku, Kumamoto City, Kumamoto 860-8556, Japan
TEL +81-96-373-5150
Email ytanaka@kumamoto-u.ac.jp

Public contact
Name of contact person
1st name Kenshi
Middle name
Last name Matsuno
Organization Kumamoto University Hospital
Division name Gastroenterology and Hepatology
Zip code 860-8556
Address 1-1-1 Honjo, Chuo-ku, Kumamoto City, Kumamoto 860-8556, Japan
TEL +81-96-373-5150
Homepage URL
Email matuken1115@gmail.com

Sponsor
Institute Kumamoto University Hospital
Institute
Department

Funding Source
Organization Kumamoto University Hospital
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 Kumamoto University Hospital
Address 1-1-1 Honjo, Chuo-ku, Kumamoto City, Kumamoto 860-8556, Japan
Tel +81-96-373-5657
Email ski-shien@jimu.kumamoto-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
2022 Year 05 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
2021 Year 11 Month 22 Day
Date of IRB
2021 Year 11 Month 22 Day
Anticipated trial start date
2022 Year 05 Month 09 Day
Last follow-up date
2025 Year 05 Month 09 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Observational study

Management information
Registered date
2022 Year 05 Month 09 Day
Last modified on
2022 Year 05 Month 09 Day


Link to view the page
URL(English) https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054375

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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