UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023233 |
|---|---|
| Receipt number | R000026694 |
| Scientific Title | Retrospective follow-up study of lymph node metastasis examination by OSNA in colorectal cancer. |
| Date of disclosure of the study information | 2016/07/20 |
| Last modified on | 2023/07/25 17:43:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Retrospective follow-up study of lymph node metastasis examination by OSNA in colorectal cancer.
Acronym
OSNA-CRC Japan multi-center follow-up study.
Scientific Title
Retrospective follow-up study of lymph node metastasis examination by OSNA in colorectal cancer.
Scientific Title:Acronym
OSNA-CRC Japan multi-center follow-up study.
Region
| Japan |
Condition
Condition
Colorectal Cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate three-year prognosis to clarify the association between recurrence and OSNA-based up-staging rate.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Three-year disease-free survival rate and three-year overall survival rate in each pathological stages, which are diagnosed based on both of OSNA and histopahtological methods.
2. Recurrence prognostic factors in the group which is diagnosed with StageII based on histopathological method.
3. Setting of cut-offs of the sum of the quantitative results of OSNA for three-year disease-free survival rate and three-year overall survival rate.
4. Three-year disease-free survival rate and three-year overall survival rate in each diagnosed group.
Key secondary outcomes
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
All patient who were analyzed in the prior study.
Key exclusion criteria
Nothing in particular
Target sample size
204
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nariaki Matsuura, MD., 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 | Hirofumi Yamamoto, M.D., Ph.D. |
Organization
Graduate School of Medicine, Osaka University
Division name
Department of Gastroenterological Surgery
Zip code
Address
2-2 Yamada-oka, Suita-City, Osaka 565-0871, Japan
TEL
06-6879-3251
Homepage URL
hyamamoto@sahs.med.osaka-u.ac.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
日本大学病院/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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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
| 2016 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study is performed as an additional study of a previous research(UMIN000023130).
Management information
Registered date
| 2016 | Year | 07 | Month | 19 | Day |
Last modified on
| 2023 | Year | 07 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026694
