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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000035419
Receipt No. R000040353
Scientific Title Prospective study using cancer registry in Japan on prognosis of patients with early esophageal cancer after curative endoscopic resection
Date of disclosure of the study information 2018/12/31
Last modified on 2018/12/31

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Basic information
Public title Prospective study using cancer registry in Japan on prognosis of patients with early esophageal cancer after curative endoscopic resection
Acronym Prospective study using cancer registry in Japan on prognosis of patients with early esophageal cancer after curative endoscopic resection
Scientific Title Prospective study using cancer registry in Japan on prognosis of patients with early esophageal cancer after curative endoscopic resection
Scientific Title:Acronym 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
1st name
Middle name
Last name Koichiro Kawaguchi
Organization Tottori University
Division name Division of Medicine and Clinical Science
Zip code
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
1st name
Middle name
Last name Koichiro Kawaguchi
Organization Tottori University
Division name Division of Medicine and Clinical Science
Zip code
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)

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 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

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
2018 Year 01 Month 14 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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