UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050935 |
|---|---|
| Receipt number | R000057202 |
| Scientific Title | A prospective observational study using ePRO-based symptom monitoring in patients with gynecologic and breast cancer |
| Date of disclosure of the study information | 2023/04/26 |
| Last modified on | 2024/10/25 09:30:10 |
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Basic information
Public title
A prospective observational study using ePRO-based symptom monitoring in patients with gynecologic and breast cancer
Acronym
Not Applicable
Scientific Title
A prospective observational study using ePRO-based symptom monitoring in patients with gynecologic and breast cancer
Scientific Title:Acronym
Not Applicable
Region
| Japan |
Condition
Condition
Gynecologic Cancer, Breast Cancer
Classification by specialty
| Hematology and clinical oncology | Surgery in general | Breast surgery |
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the feasibility of electronic symptom monitoring during cancer treatment in patients with gynecologic and breast cancer.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Total app usage rate by patients
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.Diagnosis of ovarian, cevival, uterine or breast cancer
2.Scheduled to begin systemic anticancer mono- or combination pharmacotherapy (e.g., cytotoxic anticancer agents, molecularly targeted drugs, and immune checkpoint inhibitors) within a month from enrollment
3.Written consent for the study personally obtained from the subject
4.Capable of using smartphone by themselves and/or with the support from family
5.Aged >=18 at informed consent
6.Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0, 1, or 2 at informed consent
Key exclusion criteria
1.Patients receiving cancer treatment for Synchronous cancers
2.Patients with treatment-emergent adverse events that have not resolved to baseline or Grade <= 2 according to CTCAE version 5.0.
3.Deemed otherwise unsuitable for the study by the principal investigator or other investigators
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Katsuya |
| Middle name | |
| Last name | Tsuchihara |
Organization
Exploratory Oncology Research & Clinical Trial Center, National Cancer Center
Division name
Division of Translational Informatics
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
ktsuchih@east.ncc.go.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Harano |
Organization
National Cancer Center Hospital East
Division name
Department Of Medical Oncology
Zip code
277-8577
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
TEL
04-7133-1111
Homepage URL
kharano@east.ncc.go.jp
Sponsor or person
Institute
National Cancer Center
Institute
Department
Personal name
Katsuya Tsuchihara
Funding Source
Organization
Takeda Pharmaceutical Company Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
MICIN.INC
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Cancer Center Hospital East
Address
6-5-1 Kashiwanoha, Kashiwa, Chiba
Tel
04-7133-1111
irst@ml.res.ncc.go.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
国立がん研究センター東病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 04 | Month | 26 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
There is a plan for publication in the future
Number of participants that the trial has enrolled
40
Results
There is a plan for publication in the future
Results date posted
| 2024 | Year | 10 | Month | 25 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
There is a plan for publication in the future
Participant flow
There is a plan for publication in the future
Adverse events
There is a plan for publication in the future
Outcome measures
There is a plan for publication in the future
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2023 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 04 | Month | 21 | Day |
Anticipated trial start date
| 2023 | Year | 04 | Month | 27 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
A prospective observational study using ePRO-based symptom monitoring in patients with gynecologic and breast cancer
Management information
Registered date
| 2023 | Year | 04 | Month | 26 | Day |
Last modified on
| 2024 | Year | 10 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057202
