UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023130 |
|---|---|
| Receipt number | 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 17:30:51 |
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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
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
lifescience@sysmex.co.jp
Sponsor or person
Institute
Osaka Medical Center for Cancer and Cardiovascular Diseases
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026033
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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