UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Selective Sentinel Lymph Node Dissection and a One-step Nucleic Acid Amplification Assay for the Identification of Lateral Pelvic Lymph Node Metastasis in Rectal Cancer
Title of the study (Brief title)	Sentinel OSNA assay of the lateral pelvic region
Region	Japan

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

Objectives
Narrative objectives1	The aim of this study is to evaluate the feasibility of sentinel node metastases of lateral pelvic region in locally advanced rectal cancer using the one-step nucleic acid amplification assay.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Accuracy of sentinel node metastases
Key secondary outcomes	1)Sensitivity 2)Specificity 3)Positive Predictive Value(PPV) 4)Negative Predictive Value(NPV) 5)Detection rate 6)Adverse event rate

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine
Interventions/Control_1	After Total Mesorectal excision(TME) for primary lesion, lateral pelvic node dissection was performed and picked up lymph nodes around inferior vesical artery as sentinel basin which were examined using the one-step nucleic acid amplification assay.
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	80 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Histologically proven as adenocarcinomas 2) clinical stage II or III 3) 1) Tumor located below the peritoneum. 4) Aged between 20 and 80 years old 5) ECOG Performance status of 0 or 1 6) no severe comobidity or organ disorder 7) willing to provide written informed consent
Key exclusion criteria	1) History of severe drug hypersensitivity 2) history of another malignancy within 5 years 3) Severe concurrent disease such as poorly controlled hypertension, poorly controlled diabetes, interstitial pneumonia or pulmonary fibrosis, severe chronic pulmonary emphysema, heart failure, renal failure, hepatic failure. 4) Pregnant females, possibly pregnant females, females wishing to become pregnant and nursing mothers. Males who are currently attempting to produce a pregnancy 5) Physician concludes that the patient's participation in this trial is inappropriate
Target sample size	30

Research contact person
Name of lead principal investigator	Mitsuyoshi Ota
Organization	Yokohama City University Medical Center
Division name	Gastroenterological surgery
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japan
TEL	045-261-5656
Email	m_ota@yokohama-cu.ac.jp

Public contact
Name of contact person	Mitsuyoshi Ota
Organization	Yokohama City University Medical Center
Division name	Gastroenerological Center
Address	4-57 Urafune-cho, Minami-ku, Yokohama City, 232-0024, Japa
TEL	045-261-5656
Homepage URL
Email	m_ota@yokohama-cu.ac.jp

Sponsor
Institute	Yokohama City University Medical Center
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2015 Year 07 Month 22 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 11 Month 01 Day
Anticipated trial start date	2014 Year 01 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2015 Year 07 Month 22 Day
Last modified on	2017 Year 07 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021277