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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000044266
Receipt No. 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

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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
Obsterics 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
Email 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
Email soulken@kuhp.kyoto-u.ac.jp

Sponsor
Institute Department of Gynecology and Obstetrics, Kyoto University Graduate School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050548

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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