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
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
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
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
