UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030795 |
|---|---|
| Receipt number | R000035163 |
| Scientific Title | Examination of the usefulness of the sentinel lymph node navigation for esoagogastric junctional cancer |
| Date of disclosure of the study information | 2018/01/15 |
| Last modified on | 2019/09/27 08:45:47 |
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Basic information
Public title
Examination of the usefulness of the sentinel lymph node navigation for esoagogastric junctional cancer
Acronym
Examination of the usefulness of the sentinel lymph node navigation for esoagogastric junctional cancer
Scientific Title
Examination of the usefulness of the sentinel lymph node navigation for esoagogastric junctional cancer
Scientific Title:Acronym
Examination of the usefulness of the sentinel lymph node navigation for esoagogastric junctional cancer
Region
| Japan |
Condition
Condition
Esophagogastric junctional cancer (Nishi Classification)
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
For an esophagogastric junctional cancer patient, to evaluate the usefulness about feasibility of the appropriate method choice based on the sentinel lymph node theory by inspecting it among the art of the sentinel lymph node navigation in standard operation treatment.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Detection rate of the sentinel lymph node
Key secondary outcomes
Accuracy of the sentinel lymph node
The rate of adverse events
Sentinel lymph node identification rate
distribution, metastasis situation,
metastasis detectivity,
Dectection rate of each of pathological type and tumor depth,
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Sentinel lymph node navigation
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) age20-80
2) cT1-T3N0-1 histological proven junctional cancer (Nishi classification)
3) untreated preoperatively (except for endoscopic resection)
4)ECOG PS0-1
5)capable of oral intake
6)written informed consent
Key exclusion criteria
1)pregnant and to have hisory of drug allergy or the asthma.
2)to have history of treatment for other cancer within 5 years (except for the cases that undergone endoscopic radical resection)
3) untreated other cancers
4) uncontrollable organ failure
5) active infectious diseases
6) Decison as adequate cases by a donctor in charge.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hisahiro |
| Middle name | |
| Last name | Matsubara |
Organization
Chiba University
Division name
Frontier Surgery
Zip code
260-8670
Address
1-8-1 Chuo-Ku, Chiba City, Chiba Pref.
TEL
043-226-2110
matsuhm@chiba-u.jp
Public contact
Name of contact person
| 1st name | Masayuki |
| Middle name | |
| Last name | Kano |
Organization
Chiba University
Division name
Frontier Surgery
Zip code
260-8670
Address
1-8-1 Chuo-Ku, Chiba City, Chiba Pref.
TEL
043-226-2110
Homepage URL
mkano@chiba-u.jp
Sponsor or person
Institute
Chiba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Frontier Surgery, Chiba University
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
Clinical Reseach Center, Chiba University Hospital
Address
1-8-1 Inohana Chuo-Ku, Chiba City, Chiba Pref., Japan
Tel
043-222-7171
ccrc-jim@chiba-u.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
千葉大学医学部附属病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 01 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 12 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 06 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 01 | Month | 13 | Day |
Last modified on
| 2019 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035163
