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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000043763
Receipt No. R000049960
Scientific Title Multi-institutional prospective observational study of post-treatment outcome for entire circumferential superficial esophageal cancer
Date of disclosure of the study information 2021/03/27
Last modified on 2021/05/27

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Basic information
Public title Multi-institutional prospective observational study of post-treatment outcome for entire circumferential superficial esophageal cancer
Acronym Outcome study for entire circumferential superficial esophageal cancer
Scientific Title Multi-institutional prospective observational study of post-treatment outcome for entire circumferential superficial esophageal cancer
Scientific Title:Acronym Outcome study for entire circumferential superficial esophageal cancer
Region
Japan

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

Objectives
Narrative objectives1 To clarify the clinical course (stenosis rate, prognosis, etc.) after of ESD, OPE, and CRT for entire circumferential superficial esophageal cancer, and explore the advantage and disadvantage of each initial treatment according to lesion's invasion depth and length.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Overall survival
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 1. Clinically diagnosed as esophageal squamous cell carcinoma
2. Lesions mainly located in the cervical, thoracic, and abdominal esophagus
3. The lesion's depth of invasion is clinically diagnosed as EP/LPM or MM/SM1
4. No lymph node metastasis and no distant metastasis (cN0M0)
5. The entire circumferential lesion or sub-circumferential lesion (only in the case that become or expected to become the entire circumferential mucosal defect after ESD)
6. All multiple lesions are clinically diagnosed as EP/LPM and spreading to less than 3/4 circumference of esophageal wall
7. Plaaned to perform with ESD, OPE, CRT, or RT in two months, or already performed within two weeks
8. No prior treatment of radiation therapy to the cervical chest, lung, or mediastinum field for any malignancies
9. No prior treatment for esophageal cancer, except for complete resection by EMR/ESD (shaollower than pT1a-LPM without lympovascular invasion) and fulfilling the following (1) and (2)
(1) The main lesion is located within 20 mm from the center of the scar after prior EMR/ESD
(2) The ordinally endoscopy (diameter of 9.6-10.4 mm) could not pass the esophagus deu to the scar after prior EMR/ESD
10. 20 years or older
11. Written informed consent
Key exclusion criteria Synchronous or metachronous (within 1 year) malignancy
Target sample size 200

Research contact person
Name of lead principal investigator
1st name Tomonori
Middle name
Last name Yano
Organization National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Division name Department of Gastroenterology and Endoscopy
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan
TEL 04-7133-1111
Email toyano@east.ncc.go.jp

Public contact
Name of contact person
1st name Tomohiro
Middle name
Last name Kadota
Organization National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Division name Department of Gastroenterology and Endoscopy
Zip code 277-8577
Address 6-5-1, Kashiwanoha, Kashiwa, Chiba 277-8577, Japan
TEL 04-7133-1111
Homepage URL
Email tkadota@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Institute
Department

Funding Source
Organization National Cancer Center Hospital East, Kashiwa, Chiba, Japan
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 NCC IRB office
Address 5-1-1, Tsukiji, Chuo-ku, Tokyo, Japan
Tel 03-3542-2511
Email NCC_IRBoffice@ml.res.ncc.go.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 恵佑会第二病院(北海道)
東北大学病院(宮城県)
国立がん研究センター東病院(千葉県)
国立がん研究センター中央病院(東京都)
がん研究会有明病院(東京都)
虎の門病院(東京都)
がん・感染症センター都立駒込病院(東京都)
佐久総合病院佐久医療センター(長野県)
静岡県立静岡がんセンター(静岡県)
大阪市立大学医学部附属病院(大阪府)
大阪国際がんセンター(大阪府)
兵庫県立がんセンター(兵庫県)
岡山大学病院(岡山県)
広島大学病院(広島県)
福岡大学筑紫病院(福岡県)
長崎大学病院(長崎県)

Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 27 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 Open public recruiting
Date of protocol fixation
2021 Year 03 Month 12 Day
Date of IRB
2021 Year 03 Month 17 Day
Anticipated trial start date
2021 Year 05 Month 24 Day
Last follow-up date
2029 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: Observational study

Management information
Registered date
2021 Year 03 Month 27 Day
Last modified on
2021 Year 05 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049960

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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