UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000476 |
|---|---|
| Receipt number | R000000577 |
| Scientific Title | Multi-center clinical trial for diagnostic value of sentinel node biopsy to detect lymph node metastasis in gastric cancer |
| Date of disclosure of the study information | 2006/09/01 |
| Last modified on | 2015/04/05 21:11:52 |
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Basic information
Public title
Multi-center clinical trial for diagnostic value of sentinel node biopsy to detect lymph node metastasis in gastric cancer
Acronym
Sentinel biopsy for gastric cancer
Scientific Title
Multi-center clinical trial for diagnostic value of sentinel node biopsy to detect lymph node metastasis in gastric cancer
Scientific Title:Acronym
Sentinel biopsy for gastric cancer
Region
| Japan |
Condition
Condition
Early gastric cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To test the feasibility and validity of sentinel node biopsy for the patients with gastric cancer by multi-center prospective trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sensitivity to detect lymph node metastasis based on sentinel node biopsy
Key secondary outcomes
Detection rate of sentinel nodes, The distribution and the number of sentinel nodes
Incidence of adverse effect
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Maneuver |
Interventions/Control_1
sentinel node mapping
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
cT1, T2N0 gastric cancer
Diameter of primary lesion < 4.0 cm
No indication for endoscopic treatments based on guidelines recommended by Japan Gastric Cancer Association
Single lesion
No previous treatment for gastric cancer
No previous gastric surgery
Informed consent
Key exclusion criteria
Pregnancy
Drug allergy
Asthma
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuko Kitagawa |
Organization
Keio University, School of Medicine
Division name
Department of Surgery
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo 160-8582, Japan
TEL
03-3353-1211
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Kitagawa |
Organization
Keio University, School of Medicine
Division name
Department of Surgery
Zip code
Address
TEL
Homepage URL
kitagawa@sc.itc.keio.ac.jp
Sponsor or person
Institute
Japanese Society for sentinel node navigation surgery
Institute
Department
Personal name
Funding Source
Organization
Cancer Research, Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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
| 2006 | Year | 09 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
433 patients enrolled in the study, and 397 were deemed eligible on the basis of surgical findings. SN biopsy was performed in all the patients, and the SN detection rate was 97.5% (393 of 387). Sensitivity to predict lymph node metastasis was 93% (53 of 57), and accuracy of lymph node status based on SN concept was 99% (383 of 387). Only four negative-false cases were observed, and pathological analysis revealed that three of those biopsies were deeper than pT2 or tumors>4cm, and in one of pT1N0 case, SN metastasis was limited within the region of SN basins. We observed no serious adverse events related to endoscopic tracer injection and SN mapping procedure.
(J Clin Oncol. 2013: 31:3704-10)
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
Completed
Date of protocol fixation
| 2004 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2004 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2006 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Sensitivity to detect lymph node metastasis based on sentinel node biopsy, detection rate of sentinel nodes, the distribution and the number of sentinel nodes, incidence of adverse effect are to be observed.
Management information
Registered date
| 2006 | Year | 08 | Month | 23 | Day |
Last modified on
| 2015 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000577
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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