UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Investigation of the new endoscopic findings to predict the development of esophageal cancer
Title of the study (Brief title)	Investigation of the new endoscopic findings to predict the development of esophageal cancer
Region	Japan

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

Objectives
Narrative objectives1	To investigate the endoscopic findings of background esophageal mucosa corresponding to the metachronous development of esophageal cancer.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The association between the findings of background esophageal mucosa assessed by Image-Enhanced Endoscopy and the metachronous development of esophageal 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	Not applicable
Gender	Male and Female
Key inclusion criteria	A history of superficial esophageal cancer by endoscopic resection completely. The number of lesions endoscopically resected is one or two. No additional treatment plan (surgical resection, radiotherapy, chemotherapy) immediately after endoscopic resection.
Key exclusion criteria	A history of esophagectomy. A history of radiotherapy for esophageal cancer. A presence of reflux esophagitis with erosions at the timing of endoscopic examination to assess the background esophageal mucosa. A presence of esophageal cancer at the timing of endoscopic examination to assess the background esophageal mucosa. Patients whom the investigator considered unsuitable as subjects.
Target sample size	200

Research contact person
Name of lead principal investigator	Ryu Ishihara
Organization	Osaka International Cancer Institute
Division name	Dept. of Gastrointestinal Oncology
Address	3-1-69 Otemae Chuoku Osaka
TEL	+81-6-6945-1181
Email	isihara-ry@mc.pref.osaka.jp

Public contact
Name of contact person	Kenshi Matsuno
Organization	Osaka International Cancer Institute
Division name	Dept. of Gastrointestinal Oncology
Address	3-1-69 Otemae Chuoku Osaka
TEL	+81-6-6945-1181
Homepage URL
Email	matuken1115@gmail.com

Sponsor
Institute	Osaka International Cancer Institute
Institute
Department

Funding Source
Organization	Osaka International Cancer Institute
Organization
Division
Category of Funding Organization	Local Government
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 02 Month 19 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 02 Month 06 Day
Anticipated trial start date	2018 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	The aim of this study to to predict the new risk factor of esophageal cancer.

Management information
Registered date	2018 Year 02 Month 16 Day
Last modified on	2018 Year 02 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035778