UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011973 |
|---|---|
| Receipt number | R000013984 |
| Scientific Title | Surveillance and early intervention for early HNSCC in ESCC patients |
| Date of disclosure of the study information | 2013/10/07 |
| Last modified on | 2013/10/07 00:06:11 |
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Basic information
Public title
Surveillance and early intervention for early HNSCC in ESCC patients
Acronym
Surveillance and early intervention for early HNSCC in ESCC patients
Scientific Title
Surveillance and early intervention for early HNSCC in ESCC patients
Scientific Title:Acronym
Surveillance and early intervention for early HNSCC in ESCC patients
Region
| Japan |
Condition
Condition
esophageal squamous cell carinoma
head and neck squamous cell carcinoma
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We compared the detection rate of superficial HNSCCs and frequency of the serious adverse events (loss of laryngeal function, death) related to metachronous HNSCC in each group.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Frequency of the serious adverse events (loss of laryngeal function, death) related to metachronous HNSCC.
Key secondary outcomes
Detection rate of superficial HNSCCs
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
1) newly diagnosed stage I/II/III ESCC treated with definitive treatment
2) absence of synchronous advanced cancer containing HNSCC
3) a follow-up period longer than 6 months
Key exclusion criteria
1) history of ESCC
2) stage IVA / IVB ESCC
3) any history of advanced cancer
4) a follow-up period within 6 months
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomonori Yano |
Organization
National Cancer Center Hospital East, Kashiwa, Japan
Division name
Endoscopy division
Zip code
Address
Kashiwanoha 6-5-1, Kashiwa, Chiba
TEL
04-7133-1111
toyano@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Morimoto |
Organization
National Cancer Center Hospital East, Kashiwa, Japan
Division name
Endoscopy division
Zip code
Address
Kashiwanoha 6-5-1, Kashiwa, Chiba
TEL
04-7133-1111
Homepage URL
hmorimot@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
国立がん研究センター東病院(千葉県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 07 | 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
No longer recruiting
Date of protocol fixation
| 2013 | Year | 03 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 03 | Month | 09 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
retrospective study
Management information
Registered date
| 2013 | Year | 10 | Month | 07 | Day |
Last modified on
| 2013 | Year | 10 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013984
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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