UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022517 |
|---|---|
| Receipt number | R000025959 |
| Scientific Title | Formulation of the health related QOL/PRO database in breast cancer patients |
| Date of disclosure of the study information | 2016/05/29 |
| Last modified on | 2020/06/01 13:37:41 |
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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
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
t.iwatani@marianna-u.ac.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025959
