UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015069
Receipt No. R000017444
Scientific Title Multivariate analysis of the factors causing chronic pain after breast cancer surgery
Date of disclosure of the study information 2014/09/08
Last modified on 2017/06/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Multivariate analysis of the factors causing chronic pain after breast cancer surgery
Acronym Multivariate analysis of the factors causing chronic pain after breast cancer surgery
Scientific Title Multivariate analysis of the factors causing chronic pain after breast cancer surgery
Scientific Title:Acronym Multivariate analysis of the factors causing chronic pain after breast cancer surgery
Region
Japan

Condition
Condition patients passing more than 6 months after breast cancer surgery
Classification by specialty
Breast surgery Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 This study aims to find the factors around peri-operative period causing chronic pain after breast cancer
Basic objectives2 Others
Basic objectives -Others risk factors
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Prevalence of chronic pain(continued more than 6 months after surgery)
Key secondary outcomes Severity of chronic pain(continued more than 6 months after surgery)

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
70 years-old >=
Gender Female
Key inclusion criteria female under 70 years old
patients undergoing surgery in 3 years
Key exclusion criteria over 70 years old
male
bilateral surgery at once
unilateral surgery with reconstruction or insertion of expander
ASA class 3 over
emergent surgery
analgesic user
antipsychotic or anxiolytic drug user
BMI over 35
eGFR under 50
patients diagnosed cancer recurrence or metastasis during post-operative periods
death
patients followed up by other doctors
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tomoyuki Miyazaki
Organization Yokohama city University, Sch. Medicine
Division name Dept. Anesthesiology
Zip code
Address 3-9 fukuura, kanazawa-ku,yokohama city, japan
TEL 045-787-2918
Email johney4@hotmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Tomoyuki Miyazaki
Organization Yokohama city University, Sch. Medicine
Division name Dept. Anesthesiology
Zip code
Address 3-9 fukuura, kanazawa-ku,yokohama city, japan
TEL 045-787-2918
Homepage URL
Email johney4@hotmail.com

Sponsor
Institute Yokohama City University
Institute
Department

Funding Source
Organization self-funding
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2014 Year 09 Month 08 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
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 No longer recruiting
Date of protocol fixation
2014 Year 09 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information prospective cross-sectional study

Management information
Registered date
2014 Year 09 Month 05 Day
Last modified on
2017 Year 06 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017444

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.