UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044520
Receipt number R000050867
Scientific Title Prognostic analysis of colorectal liver metastasis: multicenter retrospective observational study
Date of disclosure of the study information 2021/06/14
Last modified on 2021/06/13 16:22:52

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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 or person

Institute

Wakayama Medical University

Institute

Department

Personal name



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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050867


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name