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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN C000000059
Receipt No. R000000104
Scientific Title Evaluation of feasibility and accuracy of diagnosis using sentinel node biopsy in early gastric cancer(JCOG0302, GCSSG-SNB)
Date of disclosure of the study information 2005/08/15
Last modified on 2014/02/21

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Basic information
Public title Evaluation of feasibility and accuracy of diagnosis using sentinel node biopsy in early gastric cancer(JCOG0302, GCSSG-SNB)
Acronym Evaluation of feasibility and accuracy of diagnosis using sentinel node biopsy in early gastric cancer(JCOG0302, GCSSG-SNB)
Scientific Title Evaluation of feasibility and accuracy of diagnosis using sentinel node biopsy in early gastric cancer(JCOG0302, GCSSG-SNB)
Scientific Title:Acronym Evaluation of feasibility and accuracy of diagnosis using sentinel node biopsy in early gastric cancer(JCOG0302, GCSSG-SNB)
Region
Japan

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

Objectives
Narrative objectives1 To evaluate feasibility and accuracy of diagnosis using sentinel node biopsy in early gastric cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase II

Assessment
Primary outcomes False-negative rate
Key secondary outcomes Success rate, false-positive rate, post-operative morbidity, anaphylaxis reaction, relapse-free survival of patients with lymph node metastases

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
Maneuver
Interventions/Control_1 Gastrectomy with extemded lymphadenectomy after sentinel node biopsy
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 Preoperatively,
(1) histologically proven adenocarcinoma,
(2)T1, and 4cm or less in diameter, no tumor within 2cm from esophagogastric junction or pyloric ring,
(3) no existence of multiple foci,
(4) no prior treatment for gastric cancer,
(5) no prior surgery for gastric or duodenal ulcer
(6) written informed consent.
Intra-operatively,
(7) prior to dye injection,
(8) not laparoscopic surgery,
(9) T1,
(10) palpable of tumor or marking clips,
(11) no apparent lymph node metastasis,
(12) no severe adhesion around stomach.
Key exclusion criteria (1) anaphylaxis reaction against iodine,
(2) non-curative synchronous malignancy.
Target sample size 1550

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Hiratsuka, MD, PhD
Organization Itami municipal hospital
Division name Surgery
Zip code
Address 1-100 Koyaike, Itami, Hyogo 664-8540, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Isao Miyashiro, MD, PhD
Organization JCOG0302 Coordinating Office
Division name Gastric Surgery Division, Osaka Medical Center for Cancer and Cardiovascular Diseases
Zip code
Address 1-3-3 Nakamichi, Higashinari-ku, Osaka 537-8511, JAPAN
TEL
Homepage URL http://www.jcog.jp/
Email JCOG_sir@ml.jcog.jp

Sponsor
Institute Japan Clinical Oncology Group(JCOG)
Institute
Department

Funding Source
Organization 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 岩手医科大学(岩手県)
国立病院機構仙台医療センター(宮城県)
宮城県立がんセンター(宮城県)
山形県立中央病院(山形県)
防衛医科大学校(埼玉県)
埼玉県立がんセンター(埼玉県)
国立がんセンター東病院(千葉県)
国立がんセンター中央病院(東京都)
都立駒込病院(東京都)
都立墨東病院(東京都)
神奈川県立がんセンター(神奈川県)
新潟県立がんセンター新潟病院(新潟県)
新潟県厚生連長岡中央綜合病院(新潟県)
燕労災病院(新潟県)
富山県立中央病院(富山県)
岐阜市民病院(岐阜県)
愛知県がんセンター中央病院 (愛知県)
京都第2赤十字病院(京都府)
近畿大学医学部(大阪府)
大阪府立病院機構大阪府立成人病センター(大阪府)
国立病院機構大阪医療センター(大阪府)
大阪医科大学(大阪府)
市立豊中病院(大阪府)
市立堺病院(大阪府)
市立伊丹病院(兵庫県)
和歌山県立医科大学(和歌山県)
広島市立広島市民病院(広島県)
国立病院機構四国がんセンター(愛媛県)

Other administrative information
Date of disclosure of the study information
2005 Year 08 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.ncbi.nlm.nih.gov/pubmed/23933782
Number of participants that the trial has enrolled
Results
See the datails via "URL releasing results" above.
Also the details can be seen in the JCOG website: 
http://www.jcog.jp/en/trials/index.html
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 Terminated
Date of protocol fixation
2004 Year 01 Month 13 Day
Date of IRB
Anticipated trial start date
2004 Year 05 Month 01 Day
Last follow-up date
2012 Year 11 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2005 Year 08 Month 15 Day
Last modified on
2014 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000104

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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