UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective study using cancer registry in Japan on prognosis of patients with early esophageal cancer after curative endoscopic resection
Title of the study (Brief title)	Prospective study using cancer registry in Japan on prognosis of patients with early esophageal cancer after curative endoscopic resection
Region	Japan

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

Objectives
Narrative objectives1	To clarify the cause of death (Especially cause of death from other diseases)
Basic objectives2	Others
Basic objectives -Others	Risk factors for poor prognosis cases (Particularly the morbidity of other cancers)
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The cause of death of patients with esophageal cancer after curative resection endoscopically
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients with early esophageal cancer after endoscopic resection who had been proved curative excision histologically and had survived at least 1 year after resection
Key exclusion criteria	1. The depth reaching submucosa below 200 micro-meter. 2. Excision deep end stump is positive. 3. CT, ultrasound endoscopic examination recognizes lesions suspected of lymph node metastasis. 4. Death cases within 1 year after endoscopic treatment (regardless of cause of death)
Target sample size	200

Research contact person
Name of lead principal investigator	Koichiro Kawaguchi
Organization	Tottori University
Division name	Division of Medicine and Clinical Science
Address	36-1 Nishi-cho, Yonago City, Tottori, 683-8504 Japan
TEL	0859-38-6527
Email	koichiro@med.tottori-u.ac.jp

Public contact
Name of contact person	Koichiro Kawaguchi
Organization	Tottori University
Division name	Division of Medicine and Clinical Science
Address	36-1 Nishi-cho, Yonago City, Tottori, 683-8504 Japan
TEL	0859-38-6527
Homepage URL
Email	koichiro@med.tottori-u.ac.jp

Sponsor
Institute	Tottori University
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	鳥取大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2018 Year 12 Month 31 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2018 Year 01 Month 14 Day
Anticipated trial start date	2018 Year 04 Month 18 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	Extract follow-up endoscopes, blood collection data, clinical information annually from patients who survived for 1 year after endoscopic therapy. Ultimately, it is an observational study that carries out a prognostic survey using cancer registration.

Management information
Registered date	2018 Year 12 Month 31 Day
Last modified on	2018 Year 12 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040353