UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038784 |
|---|---|
| Receipt number | 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 12:27:47 |
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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
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
r.takahashi@jfcr.or.jp
Sponsor or person
Institute
Cancer Institute Hospital, JFCR
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044108
