UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031964 |
|---|---|
| Receipt number | R000036499 |
| Scientific Title | The prediction of lateral lymph node metastasis using One Step Nucleic Acid Amplification method in the rectal cancer |
| Date of disclosure of the study information | 2018/03/29 |
| Last modified on | 2024/04/03 12:11:48 |
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Basic information
Public title
The prediction of lateral lymph node metastasis using One Step Nucleic Acid Amplification method in the rectal cancer
Acronym
The prediction of lateral lymph node metastasis using OSNA method in the rectal cancer
Scientific Title
The prediction of lateral lymph node metastasis using One Step Nucleic Acid Amplification method in the rectal cancer
Scientific Title:Acronym
The prediction of lateral lymph node metastasis using OSNA method in the rectal cancer
Region
| Japan |
Condition
Condition
rectal cancer
Classification by specialty
| Gastrointestinal surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To adjust the object of lateral lymph node dissection
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase II
Assessment
Primary outcomes
The negative predictive value of mesorectal OSNA diagnosis for pathological lateral lymph node metastasis
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
Locally advanced lower rectal cancer undergoing mesorectal excision and lateral lymoh node dissection
Key exclusion criteria
Neoadjuvant therapy
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masakatsu Numata |
Organization
Yokohama City University
Division name
Department of Sugery
Zip code
Address
3-9 Fukuura Kanazawa-ku Yokohama Kanagawa
TEL
045-787-2645
numata@yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masakatsu Numata |
Organization
Yokohama City University
Division name
Department of Surgery
Zip code
Address
3-9 Fukuura Kanazawa-ku Yokohama Kanagawa
TEL
045-787-2645
Homepage URL
numata@yokohama-cu.ac.jp
Sponsor or person
Institute
Yokohama City University, Department of Surgery
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kanagawa Cancer Center
Yokohama Minami Kyousai Hospital
Fujisawa Syounandai Hospital
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
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 29 | 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
| 2018 | Year | 03 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
none
Management information
Registered date
| 2018 | Year | 03 | Month | 29 | Day |
Last modified on
| 2024 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036499
