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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | No longer recruiting |
Unique ID issued by UMIN | UMIN000028328 |
Receipt No. | R000032411 |
Scientific Title | Diagnostic efficacy for gastric cancer by Linked color image compare to White light image |
Date of disclosure of the study information | 2017/07/24 |
Last modified on | 2017/07/21 |
Basic information | ||
Public title | Diagnostic efficacy for gastric cancer by Linked color image compare to White light image | |
Acronym | Diagnosis for gastric cancer by Linked color image | |
Scientific Title | Diagnostic efficacy for gastric cancer by Linked color image compare to White light image | |
Scientific Title:Acronym | Diagnosis for gastric cancer by Linked color image | |
Region |
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Condition | ||
Condition | gastric cancer | |
Classification by specialty |
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Classification by malignancy | Malignancy | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate efficacy of diagnosis for gastric cancer by Linked color image compare to white light image |
Basic objectives2 | Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | Confirmatory |
Trial characteristics_2 | |
Developmental phase | Not applicable |
Assessment | |
Primary outcomes | Comparison between white light image and Linked color image for visibility score, and detection rate |
Key secondary outcomes | Accuracy, evaluation of characteristic of lesions which cannot be correctly diagnosed by white light image and Lincked color image, respectively |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Non-randomized |
Randomization unit | |
Blinding | Open -no one is blinded |
Control | Placebo |
Stratification | |
Dynamic allocation | |
Institution consideration | |
Blocking | |
Concealment |
Intervention | ||
No. of arms | 2 | |
Purpose of intervention | Diagnosis | |
Type of intervention |
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Interventions/Control_1 | short movie of LCI | |
Interventions/Control_2 | short movie of WLI | |
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients who have lesions for treatment, and were referred to our hospital, and need ditail examination | |||
Key exclusion criteria | 1. dirty stomach
2. Remnant stomach 3. Gastric tube 4. Peptic ulcer scar 5. History of endoscopic treatment 6. No consent for sedation 7. Pregnant 8. Mental illness |
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Target sample size | 95 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Jichi medical University | ||||||
Division name | Department of Internal Medicine, Division of Gastroenterology | ||||||
Zip code | |||||||
Address | 3311-1, Yakushiji, shimotsuke, Tochigi | ||||||
TEL | 0285-58-7539 | ||||||
osawa@jichi.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Jichi Medical University | ||||||
Division name | Department of Internal Medicine, Division of Gastroenterology | ||||||
Zip code | |||||||
Address | 3311-1, Yakushiji, shimotsuke, Tochigi | ||||||
TEL | 0285-58-7539 | ||||||
Homepage URL | |||||||
y-miura@jichi.ac.jp |
Sponsor | |
Institute | Jichi Medical University |
Institute | |
Department |
Funding Source | |
Organization | FUJIFILM MEDICAL Corporation |
Organization | |
Division | |
Category of Funding Organization | Profit organization |
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 |
Other administrative information | |||||||
Date of disclosure of the study information |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032411 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |