UMIN-CTR Clinical Trial

Basic information
Public title	Formulation of the health related QOL/PRO database in breast cancer patients
Acronym	Formulation of the health related QOL/PRO database in breast cancer patients
Scientific Title	Formulation of the health related QOL/PRO database in breast cancer patients
Scientific Title:Acronym	Formulation of the health related QOL/PRO database in breast cancer patients
Region	Japan

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

Objectives
Narrative objectives1	Formulation of the database of the health related QOL(utility) in breast cancer patients, and the database of the patient-reported adverse events related to breast cancer drug therapy
Basic objectives2	Others
Basic objectives -Others	The economic evaluation of breast cancer drug therapy based on this database
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. EuroQol EQ-5D-5L
Key secondary outcomes	2. Hospital Anxiety and Depression Scale 3. The European Organization for Research and Treatment of Cancer QLQ-C30 and BR23 4. Functional Assessment of Cancer Therapy-Breast, The 12-item Spiritual Well-Being Scale 5. Common Terminology Criteria for Adverse Events

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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Breast cancer patients with histopathological diagnosis 2. Patients who obtained written informed consent about this study
Key exclusion criteria	1. Mental disorder patients in active treatment 2. Ineligible patients certified by principal investigator and sub-investigators . 3. Patients participating in other clinical trials
Target sample size	5000

Research contact person
Name of lead principal investigator	1st name Tsuguo Middle name Last name Iwatani
Organization	St.Marianna University School of Medicine
Division name	Department of Breast and Endocrine Surgery
Zip code	2168511
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki
TEL	044-977-8111
Email	t.iwatani@marianna-u.ac.jp

Public contact
Name of contact person	1st name Tsuguo Middle name Last name Iwatani
Organization	St.Marianna University School of Medicine
Division name	Department of Breast and Endocrine Surgery
Zip code	2168511
Address	2-16-1 Sugao, Miyamae-ku, Kawasaki
TEL	044-977-8111
Homepage URL
Email	t.iwatani@marianna-u.ac.jp

Sponsor
Institute	St.Marianna University School of Medicine
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	St. Marianna University Scool of Medicine
Address	2-16-1 sugao Miyamaeku, Kawasaki
Tel	0449778111
Email	t.iwatani@marianna-u.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	聖マリアンナ医科大学病院（神奈川県）

Other administrative information
Date of disclosure of the study information	2016 Year 05 Month 29 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	Completed
Date of protocol fixation	2016 Year 03 Month 15 Day
Date of IRB	2016 Year 01 Month 19 Day
Anticipated trial start date	2016 Year 05 Month 30 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	This study is the prospective cohort study of breast cancer patients, and the formulation of data by using a questionnaire for the evaluation items shown in the above.

Management information
Registered date	2016 Year 05 Month 29 Day
Last modified on	2020 Year 06 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025959