UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045422 |
|---|---|
| Receipt number | R000050100 |
| Scientific Title | A registry-based study of prolonged symptomatic adverse events according to electronic Patient-Reported Outcomes (ePRO) in breast cancer patients after adjuvant chemotherapy |
| Date of disclosure of the study information | 2021/10/04 |
| Last modified on | 2025/03/12 11:58:06 |
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Basic information
Public title
A registry-based study of prolonged symptomatic adverse events according to electronic Patient-Reported Outcomes (ePRO) in breast cancer patients after adjuvant chemotherapy
Acronym
ASTRO study
Scientific Title
A registry-based study of prolonged symptomatic adverse events according to electronic Patient-Reported Outcomes (ePRO) in breast cancer patients after adjuvant chemotherapy
Scientific Title:Acronym
ASTRO study
Region
| Japan |
Condition
Condition
Breast cancer
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of prolonged symptomatic adverse events using ePRO 1 year after adjuvant chemotherapy
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of prolonged symptomatic adverse events using ePRO 1 year after adjuvant chemotherapy (CTCAE 26 Items, PRO-CTCAE 50 Items, CiTAS 18 Items, Appearance etc.)
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. 20 years over
2. Histologically diagnosed with invasive breast cancer
3. Patients who start or end adjuvant chemotherapy
4. Written informed consent
5. Patients who can input data from electronic terminals (smartphones, tablets, etc.)
6. Patients who can understand Japanese
Key exclusion criteria
1. Patients who don't have personal electronic devices(smartphones, tablets, etc.)capable of ePRO
2. History of synchronous or metachronous malignancies
3. Patients with psychiatric illnesses or symptoms that seriously disturbs activities of daily life
4. Patients with dementia that seriously disturbs activities of daily life
Target sample size
250
Research contact person
Name of lead principal investigator
| 1st name | Motohiko |
| Middle name | |
| Last name | Sano |
Organization
Hoshi University
Division name
Division of Applied Pharmaceutical Education and Research
Zip code
142-8501
Address
2-4-41, Ebara, Shinagawa-ku, Tokyo
TEL
03-5498-5834
m-sano@hoshi.ac.jp
Public contact
Name of contact person
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Nakano |
Organization
Cancer Institute Hospital
Division name
Department of Pharmacy
Zip code
135-0063
Address
3-8-31, Ariake, Koto-ku, Tokyo
TEL
03-3520-0215
Homepage URL
yasuhiro.nakano@jfcr.or.jp
Sponsor or person
Institute
Hoshi University
Institute
Department
Personal name
Funding Source
Organization
Ministry of Health, Labour and Welfare
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
Hoshi University
Address
2-4-41, Ebara, Shinagawa-ku, Tokyo 142-8501, Japan
Tel
03-3786-1011
y-hashiguchi@hoshi.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | 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
388
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 06 | Month | 17 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 10 | Month | 18 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2025 | Year | 02 | Month | 26 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study type: multicentre prospective observational study
Evaluation Items:
Adverse events
26 CTCAE 25 symptoms and 50 PRO-CTCAE 26 symptoms used in this study
ECOG Performance Status: ECOG PS
Taste Disorder Assessment Chemotherapy-Induced Taste Alteration Scale CiTAS
Backgrounds of subjects
Treatment information
Supportive care
Psychosocial context
Questionnaire
etc.
Management information
Registered date
| 2021 | Year | 09 | Month | 08 | Day |
Last modified on
| 2025 | Year | 03 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050100
