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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023863
Receipt No. R000026838
Scientific Title LCI- Further Improving Neoplasm Detection in upper GI
Date of disclosure of the study information 2016/09/30
Last modified on 2019/03/12

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Basic information
Public title LCI- Further Improving Neoplasm Detection in upper GI
Acronym LCI-FIND TRIAL
Scientific Title LCI- Further Improving Neoplasm Detection in upper GI
Scientific Title:Acronym LCI-FIND TRIAL
Region
Japan

Condition
Condition neoplasm detection in upper GI
Classification by specialty
Gastroenterology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate the usefulness of linked color imaging detecting the neoplasm of upper GI in the gastrointestinal cancer patients
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Comparison of the detection number of laryngeal, pharyngeal, esophageal,and gastric cancer between linked color imaging(LCI) and white light imaging(WLI)
Key secondary outcomes Comparison of the detection number of laryngeal, pharyngeal,esophageal,and gastric neoplasm concerning location, size, endoscopic type, impression of cancer or not between LCI and WLI

Adverse event

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Endoscopic examination with linlked color imaging before conventional white light imaging observation
Interventions/Control_2 Endoscopic examination with linked color imaging after conventional white light imaging observation
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
89 years-old >=
Gender Male and Female
Key inclusion criteria Patients who plan to undergo upper gastrointestinal endoscopy and who meet one of following

1) Patients who have history of gastrointestinal cancer (which included oral cavity, larynx, pharynx)
2) Patients whose endoscopy is performed for the present gastrointestinal cancer (which included oral cavity, larynx,pharynx)
3) Patients who have history of chemotherapy or radiotherapy
4)Patients who have history of surgical esophageal or gastric resection.
Key exclusion criteria 1)Patients taking medicines which cause the trouble in obtaining a biopsy tissue

2)Patients who have trouble in undergoing endoscopy

3)Patients with dementia or with disctuebance of consciousness
4)Patients has determined that inappropriate by principal investigator
Target sample size 1500

Research contact person
Name of lead principal investigator
1st name Mototsugu
Middle name
Last name Kato
Organization National Hospital Organization Hakodate National Hospital
Division name gastroenterology
Zip code 0418512
Address kawaharacho 18-16, Hakodate, Hokkaido
TEL 0138-51-6281
Email mkato1957@gmail.com

Public contact
Name of contact person
1st name Motitsugu
Middle name
Last name Kato
Organization National Hospital Organization Hakodate National Hospital
Division name gastroenterology
Zip code 0418512
Address kawaharacho 18-16, Hakodate, Hokkaido
TEL 0138-51-6281
Homepage URL
Email mkato1957@gmail.com

Sponsor
Institute National Hospital Organization Hakodate National Hospital
Institute
Department

Funding Source
Organization National Hospital Organization Hakodate National Hospital
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 Department of esophageal surgery, Tokyo Medical and Dental University
Address Yushima1-5-45, Bunkyoku, Tokyo ,Japan
Tel 0358035254
Email kawada.srg1@tmd.ac.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 国立病院機構函館病院(北海道)
小樽掖済会病院(北海道)
東京医科歯科大学医学部附属病院(東京都)
朝日大学歯学部附属村上記念病院(岐阜県)
京都府立医大病院(京都府)
京都府立医大北部医療センター(京都府)
四国がんセンター(愛媛県)
岡山大学病院(岡山県)
川崎医科大学病院(岡山県)
川崎医科大学附属川崎病院(岡山県)
大分大学医学部附属病院(大分県)
北海道大学医学部附属病院(北海道)
徳島大学医学部附属病院(徳島県)
鹿児島大学医学部附属病院(鹿児島県)
佐賀大学医学部附属病院(佐賀県)
東北大学医学部附属病院(宮城県)
広島大学医学部附属病院(広島県)
大阪医科大学(大阪府)
長崎大学医学部附属病院(長崎県)

Other administrative information
Date of disclosure of the study information
2016 Year 09 Month 30 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 1508
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
2016 Year 08 Month 19 Day
Date of IRB
2016 Year 09 Month 30 Day
Anticipated trial start date
2016 Year 11 Month 01 Day
Last follow-up date
2018 Year 12 Month 31 Day
Date of closure to data entry
2019 Year 01 Month 31 Day
Date trial data considered complete
2019 Year 03 Month 11 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2016 Year 08 Month 31 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026838

Research Plan
Registered date File name
2018/07/25 LCI Study研究実施計画書第11版.pdf

Research case data specifications
Registered date File name
2018/10/19 LCI-FIND CRF.pdf

Research case data
Registered date File name
2019/03/13 写真判定会議 討論結果データ解析用(20190313).xlsx


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