UMIN-CTR Clinical Trial

Basic information
Public title	Preoperative Controlling Nutritional Status plus Tumor Burden (CONUT-TB) Score for the Assessment of Prognosis after Curative Liver Resection for Hepatocellular Carcinoma
Acronym	Preoperative Controlling Nutritional Status plus Tumor Burden (CONUT-TB) Score for the Assessment of Prognosis after Curative Liver Resection for Hepatocellular Carcinoma
Scientific Title	Preoperative Controlling Nutritional Status plus Tumor Burden (CONUT-TB) Score for the Assessment of Prognosis after Curative Liver Resection for Hepatocellular Carcinoma
Scientific Title:Acronym	Preoperative Controlling Nutritional Status plus Tumor Burden (CONUT-TB) Score for the Assessment of Prognosis after Curative Liver Resection for Hepatocellular Carcinoma
Region	Japan

Condition
Condition	Hepatocellular Carcinoma
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	to investigate the value of the CONUT plus Tumor Burden (CONUT-TB) score as a prognostic predictor in patients with HCC undergoing liver resection
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	value of the CONUT plus Tumor Burden (CONUT-TB) score as a prognostic predictor in patients with HCC undergoing liver resection
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Between January 2015 and December 2018, patients with HCC underwent liver resection at our institution
Key exclusion criteria	Patients undergoing repeated liver resection and combined resection of a metastatic lesion were excluded
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Yasuyuki Middle name Last name Fukami
Organization	Aichi Medical University
Division name	Gastroenterological Surgery
Zip code	480-1195
Address	1-1 Yazakokarimata, Nagakute, Aichi
TEL	81-561-62-3311
Email	yasuyuki490225@yahoo.co.jp

Public contact
Name of contact person	1st name Yasuyuki Middle name Last name Fukami
Organization	Aichi Medical University
Division name	Gastroenterological Surgery
Zip code	480-1195
Address	1-1 Yazakokarimata, Nagakute, Aichi
TEL	81-561-62-3311
Homepage URL
Email	yasuyuki490225@yahoo.co.jp

Sponsor
Institute	Aichi Medical University
Institute
Department

Funding Source
Organization	Aichi Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Aichi Medical University
Address	1-1 Yazakokarimata, Nagakute, Aichi
Tel	81-561-62-3311
Email	yasuyuki490225@yahoo.co.jp

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	2019 Year 07 Month 14 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	81
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	2019 Year 01 Month 01 Day
Date of IRB	2019 Year 06 Month 12 Day
Anticipated trial start date	2019 Year 01 Month 01 Day
Last follow-up date	2019 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	The median follow-up period after diagnosis was 18 months

Management information
Registered date	2019 Year 07 Month 14 Day
Last modified on	2019 Year 07 Month 14 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042606