UMIN-CTR Clinical Trial

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