UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025105
Receipt number 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 2023/12/07 09:47:51

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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 Kentaro
Middle name
Last name Moriichi

Organization

Asahikawa Medical University

Division name

Division of Gastroenterology, Department of Internal Medicine

Zip code

078-8510

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 Kentaro
Middle name
Last name Moriichi

Organization

Asahikawa Medical University

Division name

Division of Gastroenterology, Department of Internal Medicine

Zip code

078-8510

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 or person

Institute

Asahikawa Medical University

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


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Asahikawa Medical University Research Ethics Committee

Address

2-1-1-1 Midorigaoka-Higashi, Asahikawa, Hokkaido 078-8510, Japan

Tel

0166-68-2297

Email

rs-kp.g@asahikawa-med.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

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

Enrolling by invitation

Date of protocol fixation

2016 Year 11 Month 10 Day

Date of IRB

2016 Year 11 Month 01 Day

Anticipated trial start date

2016 Year 12 Month 05 Day

Last follow-up date

2027 Year 03 Month 31 Day

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

2023 Year 12 Month 07 Day



Link to view the page

Value
https://center6.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