UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025105
Receipt No. R000028522
Scientific Title Novel strategies of preventions and therapies for esophageal cancer using bioactive molecules derived from oral flora or probiotics
Date of disclosure of the study information 2016/12/05
Last modified on 2016/12/01

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Novel strategies of preventions and therapies for esophageal cancer using bioactive molecules derived from oral flora or probiotics
Acronym Novel strategies of preventions and therapies for esophageal cancer using bioactive molecules derived from oral flora or probiotics
Scientific Title Novel strategies of preventions and therapies for esophageal cancer using bioactive molecules derived from oral flora or probiotics
Scientific Title:Acronym Novel strategies of preventions and therapies for esophageal cancer using bioactive molecules derived from oral flora or probiotics
Region
Japan

Condition
Condition esophageal squamous cell carcinoma, esophageal adenocarcinoma, esophageal squamous dysplasia, Barrett's esophagus
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information YES

Objectives
Narrative objectives1 To develop novel therapy for esophageal cancer, including precancerous lesions, using bioactive molecules derived from oral bacteria and probiotics
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes To detect the oral bacteria related to the pathogenesis of esophageal cancer/precancerous lesion
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients with esophageal cancer and precancerous lesions who undergo esophagogastroduodenoscopy are enrolled the study.
As a control group, patients without esophageal abnormalities who undergo esophagogastroduodenoscopy are enrolled the study.
Key exclusion criteria 1. In case patients would like to exclude the study.
2. In case the doctors in charge of the study judge patients should be excluded the study due to general condition or treatment progress.
3. In case the study is canceled.
4. In case the doctors in charge of the study judge patients should be excluded due to any other reasons.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kentaro Moriichi
Organization Asahikawa Medical University
Division name Division of Gastroenterology and Hematology/Oncology Department of Medicine
Zip code
Address 2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, 078-8510, Japan
TEL 0166-68-2462
Email morimori@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kentaro Moriichi
Organization Asahikawa Medical University
Division name Division of Gastroenterology and Hematology/Oncology Department of Medicine
Zip code
Address 2-1-1-1, Midorigaoka-higashi Asahikawa, Hokkaido, 078-8510, Japan
TEL 0166-68-2462
Homepage URL
Email morimori@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization none
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
Address
Tel
Email

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
2016 Year 12 Month 05 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
2016 Year 11 Month 10 Day
Date of IRB
Anticipated trial start date
2016 Year 12 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Relationship between oral and esophageal flora and esophageal lesions

Management information
Registered date
2016 Year 12 Month 01 Day
Last modified on
2016 Year 12 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028522

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.