UMIN-CTR Clinical Trial

Basic information
Public title	Influence of nonalcoholic fatty liver disease on locally advanced breast cancer: a retrospective cohort study
Acronym	Influence of NAFLD on LABC
Scientific Title	Influence of nonalcoholic fatty liver disease on locally advanced breast cancer: a retrospective cohort study
Scientific Title:Acronym	Influence of NAFLD on LABC: a retrospective cohort study
Region	Japan

Condition
Condition	locally advanced breast cancer
Classification by specialty	Breast surgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To investigate the association between NAFLD and the prognosis and morbidity of patients with LABC
Basic objectives2	Others
Basic objectives -Others	Association with prognosis
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Recurrence-free survival(RFS)
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	20 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	stage III breast cancer who underwent radical surgery
Key exclusion criteria	inflammatory breast cancer, concurrent malignancies, or previous malignant diseases within 5 years
Target sample size	44

Research contact person
Name of lead principal investigator	1st name Tomoe Middle name Last name Taji
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Breast surgery
Zip code	6608550
Address	2-17-77, Higashi naniwa cho, Amagasaki
TEL	06-6480-7000
Email	tajit.mutsu@gmail.com

Public contact
Name of contact person	1st name Tomoe Middle name Last name Taji
Organization	Hyogo Prefectural Amagasaki General Medical Center
Division name	Breast surgery
Zip code	6608550
Address	2-17-77, Higashi naniwa cho, Amagasaki
TEL	06-6480-7000
Homepage URL
Email	tajit.mutsu@gmail.com

Sponsor
Institute	Hyogo Prefectural Amagasaki General Medical Center
Institute
Department

Funding Source
Organization	Self funding
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	Hyogo Prefectural Amagasaki General Medical Center
Address	2-17-77, Higashi naniwa cho, Amagasaki
Tel	0664807000
Email	agmc.irb@gmail.com

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 02 Month 11 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	44
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	2020 Year 05 Month 11 Day
Date of IRB	2020 Year 05 Month 27 Day
Anticipated trial start date	2020 Year 05 Month 11 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	RFS was defined as the duration from the date of biopsy to the date of death or distant recurrence, local recurrence, or diagnosis of secondary cancer. Survival confirmation was the last visit to our hospital.

Management information
Registered date	2021 Year 02 Month 09 Day
Last modified on	2021 Year 02 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049423