UMIN-CTR Clinical Trial

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
Email	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
Email	numata@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University, Department of Surgery
Institute
Department

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
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

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	Open public recruiting
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
Date trial data considered complete
Date analysis concluded

Other
Other related information	none

Management information
Registered date	2018 Year 03 Month 29 Day
Last modified on	2021 Year 04 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036499

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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