UMIN-CTR Clinical Trial

Basic information
Public title	Prognostic analysis of colorectal liver metastasis: multicenter retrospective observational study
Acronym	Prognostic analysis of colorectal liver metastasis: multicenter retrospective observational study
Scientific Title	Prognostic analysis of colorectal liver metastasis: multicenter retrospective observational study
Scientific Title:Acronym	Prognostic analysis of colorectal liver metastasis: multicenter retrospective observational study
Region	Japan

Condition
Condition	colorectal liver metastasis
Classification by specialty	Hepato-biliary-pancreatic surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim is to retrospectively estimate prognostic impact of perioperative interventions and their perioperative courses, and contribute to the judgment in indication of perioperative interventions.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Prognostic impact of perioperative interventions
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	Eligible patients were 1. underwent hepatectomy during January 2005 to August 2019 2. pathologically proved as colorectal liver metastasis.
Key exclusion criteria	Patients with non-colorectal liver metastasis were excluded.
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Masaki Middle name Last name Ueno
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
Address	811-1 Kimiidera, Wakayama 641-8510, JAPAN
TEL	073-441-0613
Email	ma@wakayama-med.ac.jp

Public contact
Name of contact person	1st name Masaki Middle name Last name Ueno
Organization	Wakayama Medical University
Division name	Second Department of Surgery
Zip code	641-8510
Address	811-1 Kimiidera, Wakayama 641-8510, JAPAN
TEL	073-441-0613
Homepage URL
Email	ma@wakayama-med.ac.jp

Sponsor
Institute	Wakayama Medical University
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)

IRB Contact (For public release)
Organization	Research Ethics Committee of Wakayama Medical University
Address	811-1 Kimiidera, Wakayama 641-8509, JAPAN
Tel	073-447-2300
Email	wa-rinri@wakayama-med.ac.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	2021 Year 06 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	615
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 08 Month 19 Day
Date of IRB	2019 Year 10 Month 07 Day
Anticipated trial start date	2019 Year 10 Month 18 Day
Last follow-up date	2021 Year 03 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded

Other

Other related information

The study protocol is disclosed in an opt-out format on the institutional web-site, giving an opportunity to refuse consent. If there is a disagreement application during the investigation period, the relevant data will be deleted. The following variables are collected: 1. Baseline characteristics Age, gender, ASA, medical history, degree of liver damage, data of preoperative blood exam., data of pathological findings, surgical procedure, (neo)adjuvant chemotherapy setting. 2. Evaluation variables Combination of surgery and perioperative chemotherapy, their influence on recurrence-free interval and overall survival, re-recurrence pattern, treatment modality selected for re-recurrent lesions.

Management information
Registered date	2021 Year 06 Month 13 Day
Last modified on	2021 Year 06 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050867