UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053265 |
|---|---|
| Receipt number | R000060787 |
| Scientific Title | A prospective study of bone mineral density changes in patients during perioperative chemotherapy for breast cancer |
| Date of disclosure of the study information | 2024/01/04 |
| Last modified on | 2024/01/04 18:31:47 |
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Basic information
Public title
A prospective study of bone mineral density changes in patients during perioperative chemotherapy for breast cancer
Acronym
Bone density change study during perioperative chemotherapy for breast cancer
Scientific Title
A prospective study of bone mineral density changes in patients during perioperative chemotherapy for breast cancer
Scientific Title:Acronym
Bone density change study during perioperative chemotherapy for breast cancer
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 evaluate changes in bone mineral density in patients during perioperative chemotherapy for breast cancer
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Rate of decrease in bone mineral density after 4 courses of chemotherapy
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
chemotherapy
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 undergoing perioperative chemotherapy in which steroids are administered for antiemetic purposes
2) The patients who can assess bone density periodically
3) Adult patient aged over 20 years
4) The patient who have been fully informed of the study and who have given written consent of their own free will
Key exclusion criteria
1) The patients for whom regular bone density testing is not possible
2) THe patients younger than 20 years of age
3) The patients diagnosed with osteoporosis by bone density test
4) The patients using drugs for osteoporosis
5) The patients who are regularly using steroids
6) The patients who judged a study doctor to be inappropriate as subjects
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Hideaki |
| Middle name | |
| Last name | Okada |
Organization
Hyogo Prefectural Harima Himeji General Medical Center
Division name
Medical Oncology and Hematology
Zip code
670-8560
Address
3-264 Kamiya-cho, Himeji City, Hyogo, Japan
TEL
079-289-5080
shumei_oka@joy.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Hideaki |
| Middle name | |
| Last name | Okada |
Organization
Hyogo Prefectural Harima Himeji General Medical Center
Division name
Medical Oncology and Hematology
Zip code
670-8560
Address
3-264 Kamiya-cho, Himeji City, Hyogo, Japan
TEL
079-289-5080
Homepage URL
shumei_oka@joy.ocn.ne.jp
Sponsor or person
Institute
Hyogo Prefectural Harima Himeji General Medical Center
Institute
Department
Personal name
Funding Source
Organization
nothing
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
Hyogo Prefectural Harima Himeji General Medical Center
Address
3-264 Kamiya-cho, Himeji City, Hyogo, Japan
Tel
079-289-5080
Tomomi_Tanikawa@pref.hyogo.lg.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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 04 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 04 | Day |
Last modified on
| 2024 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060787
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
