UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049280 |
|---|---|
| Receipt number | R000055744 |
| Scientific Title | Survey of the data needs for endpoints on side effects of drug therapy in breast cancer patients. |
| Date of disclosure of the study information | 2022/10/31 |
| Last modified on | 2024/11/22 21:42:44 |
* 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
Survey of the data needs for endpoints on side effects of drug therapy in breast cancer patients.
Acronym
Survey of the data needs for endpoints on side effects of drug therapy in breast cancer patients.
Scientific Title
Survey of the data needs for endpoints on side effects of drug therapy in breast cancer patients.
Scientific Title:Acronym
Survey of the data needs for endpoints on side effects of drug therapy in breast cancer patients.
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Hematology and clinical oncology | Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To clarify the endpoints for side effects required in clinical research from the patient's perspective in order to reduce anxiety about drug therapy for breast cancer patients as much as possible.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
(1) Side effects you have experienced
(2) Side effects you have experienced for which a solution has been found
(3) Side effects to avoid
(4) Information you wanted to know about individual side effects before treatment
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Patient is being treated or is under follow-up observation after treatment for breast cancer at a medical institution
2) Has diagnosis with breast cancer in 2002 or later
3) Has prior anti-breast cancer treatment with chemotherapy, molecular targeted drugs, or immune checkpoint inhibitors
4) Age 18 years or older
5) Has initial diagnosis of breast cancer stage 1 to 4
6) Has obtained consent to participate in this study via the Web
Key exclusion criteria
1) Patients who expressed nonparticipation in the study prior to data fixation
2) Market research, advertising and marketing, press, healthcare professionals,or pharmaceutical company personnel
3) Persons unable to complete the questionnaire in person
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Masaharu |
| Middle name | |
| Last name | Hanai |
Organization
Daiichi Sankyo Co., Ltd.
Division name
Oncolosy Medical Science Department
Zip code
103-8426
Address
3-5-1,Nihonbashi-Honcho,Chuou-ku,Tokyo,Japan
TEL
03-6225-1186
minami.reiko.fv@daiichisankyo.co.jp
Public contact
Name of contact person
| 1st name | Sakurako |
| Middle name | |
| Last name | Okayasu |
Organization
QLife.,Co,Ltd.
Division name
Strategic Solution Plannning & Development Dept
Zip code
105-0001
Address
3-8-21,Tranomon33 Mori-Bld.10F Tranomon, Minato-Ku,Tokyo,Japan
TEL
05017516834
Homepage URL
breast-cancer@qlife.co.jp
Sponsor or person
Institute
Daiichi Sankyo Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Daiichi-Sankyo.Co,Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation TOUKEIKAI Kitamachi Clinic ERB
Address
1-1-3,Kichijoji-kitamachi,Musashino-shi,Tokyo,180-0001,Japan
Tel
03-6779-8116
chi-pr-ec-kitamachi@cmicgroup.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
| 2022 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
https://bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-024-03355-x
Publication of results
Published
Result
URL related to results and publications
https://bmcwomenshealth.biomedcentral.com/articles/10.1186/s12905-024-03355-x
Number of participants that the trial has enrolled
435
Results
The survey results showed that there are still several unmet medical needs due to inadequate solutions for side effects in breast cancer treatment. Furthermore, it became clear that patients have different information needs regarding different types of side effects.
Results date posted
| 2024 | Year | 11 | Month | 22 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2024 | Year | 10 | Month | 03 | Day |
Baseline Characteristics
Patients diagnosed of breast cancer in 2002 or later who have experienced prior treatment with chemotherapy, molecular targeted agents, or immune checkpoint inhibitors for breast cancer.
Participant flow
Of the 686 patients who obtained consent, 435 patients were analyzed after excluding 251 patients who did not meet the eligibility criteria.
Adverse events
None
Outcome measures
(1) Side effects you have experienced
(2) Side effects you have experienced for which a solution has been found
(3) Side effects to avoid
(4) Information you wanted to know about individual side effects before treatment
Plan to share IPD
IPD sharing Plan description
None
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 10 | Month | 31 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
| 2023 | Year | 04 | Month | 10 | Day |
Date analysis concluded
Other
Other related information
Questionnaire survey of anonymized patient panel
Management information
Registered date
| 2022 | Year | 10 | Month | 20 | Day |
Last modified on
| 2024 | Year | 11 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055744
