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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023130
Receipt No. R000026033
Scientific Title Lymph node metastasis detection by OSNA in colon cancer: A prospective multicenter trial in Japan
Date of disclosure of the study information 2016/07/15
Last modified on 2016/07/19

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Basic information
Public title Lymph node metastasis detection by OSNA in colon cancer: A prospective multicenter trial in Japan
Acronym Lymph node metastasis detection by OSNA in colon cancer: A prospective multicenter trial in Japan
Scientific Title Lymph node metastasis detection by OSNA in colon cancer: A prospective multicenter trial in Japan
Scientific Title:Acronym Lymph node metastasis detection by OSNA in colon cancer: A prospective multicenter trial in Japan
Region
Japan

Condition
Condition Colorectal cancer
Classification by specialty
Gastrointestinal surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To examine the clinical stage when OSNA examination result is added to the standard pathological one.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Phase IV

Assessment
Primary outcomes To seek proportion of cases which are OSNA examination positive and pathological examination negative.
Key secondary outcomes To find out predictive factors of metastasis.

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. Be diagnosed with colorectal cancer including colon cancer and/or rectal cancer, clinically staged No or N1. Limited to Ra and Rs in rectal cancer.
2. Signed informed consent.
Key exclusion criteria 1. who lack the capacity to consent.
2. Who receives/received preoperative chemotherapy.
3. Who is diagnosed with Rb.
4. Active double cancer.
5. who attending physicians consider to be inappropriate due to other reasons m
Target sample size 225

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Nariaki Matsuura, M.D., Ph.D.
Organization Osaka Medical Center for Cancer and Cardiovascular Diseases
Division name President
Zip code
Address 3-3 Nakamichi 1-Chome, Higashinari-ku, Osaka, 537-8511 Japan
TEL 06-6972-1181
Email nmatsuura@mc.pref.osaka.jp

Public contact
Name of contact person
1st name
Middle name
Last name Contact for Marketing
Organization Sysmex Corporation
Division name Life Science Product Engineering
Zip code
Address 4-4-4 Takatsukadai, Nishiku, Kobe 651-2271, Japan
TEL 078-992-7055
Homepage URL
Email lifescience@sysmex.co.jp

Sponsor
Institute Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department

Funding Source
Organization Sysmex Corporation
Organization
Division
Category of Funding Organization Profit 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 大分大学/Oita University
大阪大学医学部附属病院/Osaka University
大阪府立成人病センター/Osaka Medical Center for Cancer and Cardiovascular Diseases
関西ろうさい病院/Kansai Rosai Hospital
札幌医科大学/Sapporo Medical Univeristy
市立吹田市民病院/Suita Municipal Hospital
駿河台日本大学病院/Surugadai Nihon University Hospital
東京女子医科大学/Tokyo Women’s Medical Univiersity
栃木県立がんセンター/Tochigi Cancer Center
兵庫医科大学病院/Hyogo College of Medicine
箕面市立病院/Minoh City Hospital
シスメックス株式会社/Sysmex Corporation

Other administrative information
Date of disclosure of the study information
2016 Year 07 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/26438440
Number of participants that the trial has enrolled
Results
The concordance rate between 1 slice hematoxylin/eosin and OSNA assay was 95.7 % (1,842/1925 lymph nodes). The sensitivity and specificity of the OSNA assay were 86.2 % (125/145) and 96.5 % (1717/1780), respectively. Among 124 node-negative patients (pN0), the respective upstaging rates of pStages I, IIA, IIB, and IIC were 2.0 % (1/50), 17.7 % (11/62), 12.5 % (1/8), and 25 % (1/4). OSNA-positive patients had deeper invasion to the colonic wall and severe lymphatic invasion (P = 0.048 and P = 0.004, respectively).
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
2012 Year 02 Month 20 Day
Date of IRB
Anticipated trial start date
2012 Year 04 Month 01 Day
Last follow-up date
2013 Year 08 Month 31 Day
Date of closure to data entry
2014 Year 03 Month 04 Day
Date trial data considered complete
2014 Year 06 Month 16 Day
Date analysis concluded
2014 Year 07 Month 18 Day

Other
Other related information Patient enrollment: patients from 11 institutes who met eligibility criteria of the study between the periods after IRB approval until August of 2013 were enrolled in the study.

Management information
Registered date
2016 Year 07 Month 12 Day
Last modified on
2016 Year 07 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026033

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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