UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017458 |
|---|---|
| Receipt number | R000020071 |
| Scientific Title | Intensive surveillance for head and neck cancer in patients with esophageal squamous cell carcinoma - A Prospective Multicenter Cohort Study |
| Date of disclosure of the study information | 2015/05/08 |
| Last modified on | 2015/05/08 00:59:50 |
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Basic information
Public title
Intensive surveillance for head and neck cancer in patients with esophageal squamous cell carcinoma - A Prospective Multicenter Cohort Study
Acronym
CHIBA NBI skill up study
Scientific Title
Intensive surveillance for head and neck cancer in patients with esophageal squamous cell carcinoma - A Prospective Multicenter Cohort Study
Scientific Title:Acronym
CHIBA NBI skill up study
Region
| Japan |
Condition
Condition
Head and neck squamous cell carcinoma (HNSCC)
Classification by specialty
| Gastroenterology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the usefulness of the training program about the endoscopic head and neck surveillance for beginner endoscopists.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Detection rate of histologically confirmed HNSCC
Key secondary outcomes
1) Quality of endoscopic images
2) Examination time
3) Positive predictive value (PPV) for diagnosis of HNSCC
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) Patients with histologically confirmed esophageal squamous cell carcinoma.
2) patients who recieve upper gastrointestinal endoscopy.
3) Patients who are at least 20 years of age.
4) Patients who have provided written informed consent.
Key exclusion criteria
1) Patients with head and neck cancer.
2) Patients with a history of laryngectomy.
3) Patients with a history of radiotherapy for pharyngolaryngeal region.
4) Patients who have already enrolled in the study.
Target sample size
550
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yano Tomonori |
Organization
National Cancer Center Hospital East, Kashiwa, Japan
Division name
Department of Gastroenterology, Endoscopy division
Zip code
Address
Kashiwanoha 6-5-1, Kashiwa, Chiba, Japan
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
Department of Gastroenterology, Endoscopy division
Zip code
Address
Kashiwanoha 6-5-1, Kashiwa, Chiba, Japan
TEL
04-7133-1111
Homepage URL
hmorimot@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
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)、千葉県がんセンター(千葉県)、東京女子医科大学八千代医療センター(千葉県)、総合病院国保旭中央病院(千葉県)、東京歯科大学市川総合病院(千葉県)、千葉労災病院(千葉県)、東邦大学医療センター佐倉病院(千葉県)、千葉市立海浜病院(千葉県)、化学療法研究所附属病院(千葉県)、千葉西総合病院(千葉県)、亀田総合病院(千葉県)、千葉大学医学部附属病院(千葉県)、東京慈恵会医科大学附属柏病院(千葉県)、帝京大学ちば総合医療センター(千葉県)、千葉徳洲会病院(千葉県)、新東京病院(千葉県)、順天堂大学医学部附属浦安病院(千葉県)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 05 | Month | 08 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 11 | Month | 19 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | 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
A multicenter prospective observational study
Management information
Registered date
| 2015 | Year | 05 | Month | 08 | Day |
Last modified on
| 2015 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020071
