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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000476
Receipt No. 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

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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
Email

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
Email kitagawa@sc.itc.keio.ac.jp

Sponsor
Institute Japanese Society for sentinel node navigation surgery
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000577

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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