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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000011973
Receipt No. 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

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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
Email 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
Email hmorimot@east.ncc.go.jp

Sponsor
Institute National Cancer Center Hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013984

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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