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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038784
Receipt No. R000044108
Scientific Title Prospective feasibility study for single-tracer sentinel node mapping by indocyanine green fluorescence and one-step nucleic acid amplification assay in laparoscopic gastrectomy as additional surgery after noncurative endoscopic resection (eCuraC)
Date of disclosure of the study information 2019/12/04
Last modified on 2019/12/04

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Basic information
Public title Prospective feasibility study for single-tracer sentinel node mapping by indocyanine green fluorescence and one-step nucleic acid amplification assay in laparoscopic gastrectomy as additional surgery after noncurative endoscopic resection (eCuraC)
Acronym Prospective feasibility study for single-tracer sentinel node mapping by ICG fluorescence and OSNA assay in laparoscopic gastrectomy as additional surgery after noncurative endoscopic resection (eCuraC)
Scientific Title Prospective feasibility study for single-tracer sentinel node mapping by indocyanine green fluorescence and one-step nucleic acid amplification assay in laparoscopic gastrectomy as additional surgery after noncurative endoscopic resection (eCuraC)
Scientific Title:Acronym Prospective feasibility study for single-tracer sentinel node mapping by ICG fluorescence and OSNA assay in laparoscopic gastrectomy as additional surgery after noncurative endoscopic resection (eCuraC)
Region
Japan

Condition
Condition gastric cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To demonstrate the feasibility and safety of sentinel node mapping by single-tracer ICG fluorescence imaging, with the intraoperative diagnosis of lymph node metastasis by OSNA assay, during laparoscopic gastrectomy for gastric cancer after noncurative endoscopic resection (eCuraC)
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The feasibility and safety
Key secondary outcomes

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) Aged 20 or older
2) Status post endoscopic resection
3) Diagnosed as cT1N0M0 gastric cancer by preoperative imaging studies
4) Single lesion
5) Tumor diameter less than 40 mm
6) Expression of CK19 in gastric cancer
7) Patient's approval
Key exclusion criteria 1) Status post gastrectomy
2) Lesion with esophageal or duodenal invasion
3) Patients during pregnancy, with iodine allergy, or with bronchial asthma
4) Patients attending surgeons has determined ineligible
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Souya
Middle name
Last name Nunobe
Organization Cancer Institute Hospital
Division name Department of Gastroenterological Surgery
Zip code 1358550
Address 3-8-31, Ariake, Koto-ku, Tokyo
TEL 03-3520-0111
Email souya.nunobe@jfcr.or.jp

Public contact
Name of contact person
1st name Ryo
Middle name
Last name Takahashi
Organization Cancer Institute Hospital
Division name Department of Gastroenterological Surgery
Zip code 1358550
Address 3-8-31, Ariake, Koto-ku, Tokyo
TEL 03-3520-0111
Homepage URL
Email r.takahashi@jfcr.or.jp

Sponsor
Institute Cancer Institute Hospital, JFCR
Institute
Department

Funding Source
Organization Sysmex 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 Cancer Institute Hospital
Address 3-8-31, Ariake, Koto-ku, Tokyo
Tel 03-3520-0111
Email r.takahashi@jfcr.or.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

Other administrative information
Date of disclosure of the study information
2019 Year 12 Month 04 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
2019 Year 10 Month 09 Day
Date of IRB
Anticipated trial start date
2020 Year 01 Month 01 Day
Last follow-up date
2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The feasibility and safety

Management information
Registered date
2019 Year 12 Month 04 Day
Last modified on
2019 Year 12 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044108

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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