UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043763 |
|---|---|
| Receipt number | 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 | 2023/03/28 16:18:18 |
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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 MM/SM1 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-MM 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
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
tkadota@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital East, Kashiwa, Chiba, Japan
Institute
Department
Personal name
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
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
| 2023 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049960
