臨床研究等提出・公開システム

Japanese

Date of registration	Oct. 13, 2021
Last modified on	Oct. 13, 2021
Trial ID	jRCT1050210104

Scientific Title	A retrospective clinical study of pain and sensory changes after breast cancer surgery (A retrospective clinical study of pain and sensory changes after breast cancer surgery)
Public Title	A retrospective clinical study of pain and sensory changes after breast cancer surgery (A retrospective clinical study of pain and sensory changes after breast cancer surgery)

Contact for Scientific Queries	Name	Shimazu Kenzo
	Affiliation	Graduate School of Medicine, Osaka University
	Address	2-2-E10 yamadaoka, suita, Osaka
	Telephone	+81-6-6879-3772
	E-mail	kshimazu@onsurg.med.osaka-u.ac.jp
Contact for Public Queries	Name	Abe Kaori
	Affiliation	Graduate School of Medicine, Osaka University
	Address	2-2-E10 yamadaoka, suita, Osaka
	Telephone	+81-6-6879-3772
	E-mail	abe216@dmail.plala.or.jp

Recruitment status	Recruiting

Anticipated date of first enrollment		Oct. 13, 2021
Actual date of first enrollment
Target sample size		140
Study Type		Observational
Study Design	allocation
	masking
	control
	assignment
	purpose
Key inclusion & exclusion criteria	Inclusion Criteria	(1) Patients who have undergone breast cancer surgery for at least 3 months (2) Age: patients over 20 at the time of acquiring consent (3) Gender: female (4) Patients who have consented to particpate in this study after receiving sufficient explanation for this study and gained sufficient understandings
	Exclusion Criteria	(1) Patients with distant metastasis or recurrence of breast cancer (2) A patients who were judged as inappropriate as a research subject by the research director
	Age Minimum	20age old over
	Age Maximum	No limit
	Gender	Female
Health Condition(s) or Problem(s) Studied		breast cancer
Intervention(s)
Health Condition(s) Keyword
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Incidence and pain intensity of postoperative persistent pain after breast cancer surgery
Secondary Outcome(s)		Association of the incidence of persistent pain after breast cancer surgery with factors such as non-surgical treatment, preoperative pain, perception, emotion, and daily activities

Primary Sponsor	Osaka University Hospital

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support	Japan Agency for Medical Research and development
Secondary Sponsor	Not applicable

Name of Certified Review Board	Ethical Review Board of Osaka University Hospital
Address	2-2 Yamadaoka, Suita, Osaka
Telephone	+81-6-6210-8296
E-Mail	handai-nintei@hp-crc.med.osaka-u.ac.jp
Approval Status	Approval
Date of approval	Sept. 16, 2021

Plan to share IPD	Yes
Plan description	Information containing the personal information of research subjects to be collected in this study will be anonymized by deleting personal information such as names and addresses when collecting information from electronic medical records, assigning identification codes for research purposes, and creating a correspondence table. The corresponding list will be kept strictly by the personal information manager at each research institution. Only anonymized information will be handled when transferring information between research institutions. Information that can be used to identify patients in the questionnaire survey for this study will be deleted, and an identification code for research purposes will be assigned and managed. The personal information manager will manage the list of numbers assigned to patients.

Plan to share IPD

Yes

Plan description

Information containing the personal information of research subjects to be collected in this study will be anonymized by deleting personal information such as names and addresses when collecting information from electronic medical records, assigning identification codes for research purposes, and creating a correspondence table. The corresponding list will be kept strictly by the personal information manager at each research institution. Only anonymized information will be handled when transferring information between research institutions. Information that can be used to identify patients in the questionnaire survey for this study will be deleted, and an identification code for research purposes will be assigned and managed. The personal information manager will manage the list of numbers assigned to patients.

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none