UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044266 |
|---|---|
| Receipt number | R000050548 |
| Scientific Title | Development of database and study of health care for gynecologic malignant patients using mobile applications |
| Date of disclosure of the study information | 2021/05/19 |
| Last modified on | 2021/05/19 17:23:42 |
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Basic information
Public title
Development of database and study of health care for gynecologic malignant patients using mobile applications
Acronym
Development of database and study of health care for gynecologic malignant patients using mobile applications
Scientific Title
Development of database and study of health care for gynecologic malignant patients using mobile applications
Scientific Title:Acronym
Development of database and study of health care for gynecologic malignant patients using mobile applications
Region
| Japan |
Condition
Condition
Development of database and study of health care for gynecologic malignant patients using mobile applications
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To create a comprehensive data base of daily life (lifelog), patient-reported outcomes (PRO), biomaterial indicators (blood, tissue, etc.), and medical information.
To search for parameters that affect treatment outcomes and QOL using the databased life logs
To clarify the relationship between lifelog and molecular biology related to treatment outcome and QOL.
To develop an application to manage QOL using life logs.
Basic objectives2
Others
Basic objectives -Others
Exploration of life logs related to treatment outcomes and QOL
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Exploration of life logs related to treatment outcomes and QOL
Key secondary outcomes
Elucidation of the molecular biological background of life logs related to treatment outcomes and QOL
Development of an application to manage QOL using life logs
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
Female
Key inclusion criteria
1 Gynecological cancer diagnosed at the Department of Obstetrics and Gynecology, Kyoto University Hospital, or at a joint research facility.
2 All stages, including recurrence.
3 Women aged 18 years or older at the time of consent/enrollment date.
4 Able to prepare and use a smart phone or tablet terminal.
Key exclusion criteria
1 Patients who do not have sufficient judgment, who are unconscious, or who need consideration for the name of the disease
2 Metastatic cancer
3 Patients who are unable to handle the application
4 Patients with serious life-threatening complications
5 Patients whom the principal investigator judges inappropriate for inclusion in the study
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Masaki |
| Middle name | |
| Last name | Mandai |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gynecology and Obstetrics
Zip code
606-8507
Address
Shougoin Kawaharachou 54, Sakyouku, Kyoto pref.
TEL
0757513269
mandai@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Ken |
| Middle name | |
| Last name | Yamaguchi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Gynecology and Obstetrics
Zip code
606-8507
Address
Shougoin Kawaharachou 54, Sakyouku, Kyoto pref.
TEL
0757513269
Homepage URL
soulken@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Mirai 2021
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto
Tel
075-753-4680
ethcom@kuhp.kyoto-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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 05 | Month | 19 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 02 | Month | 18 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 17 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients diagnosed with gynecological cancer at the Department of Obstetrics and Gynecology, Kyoto University Hospital, and collaborative research facilities, who meet the eligibility criteria, will be asked to participate in an observational study using three applications to collect life logs and patient-reported outcomes (PROs) to explore life logs related to treatment outcomes and QOL.
Management information
Registered date
| 2021 | Year | 05 | Month | 19 | Day |
Last modified on
| 2021 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050548
| 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 |
