UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054460 |
|---|---|
| Receipt number | R000062099 |
| Scientific Title | Development of an algorithm for measuring QOL indicators, mainly fatigue during chemotherapy for gynecological cancer patients. |
| Date of disclosure of the study information | 2024/06/30 |
| Last modified on | 2024/05/22 16:28:42 |
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Basic information
Public title
Development of an algorithm for measuring QOL indicators, mainly fatigue during chemotherapy for gynecological cancer patients.
Acronym
JGOG9007
Scientific Title
Development of an algorithm for measuring QOL indicators, mainly fatigue during chemotherapy for gynecological cancer patients.
Scientific Title:Acronym
JGOG9007
Region
| Japan |
Condition
Condition
gynecological malignancy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To detect adverse events during chemotherapy in patients with primary gynecological cancer based on changes in HRV
Basic objectives2
Others
Basic objectives -Others
Development of Daily PRO
To detect adverse events during chemotherapy in patients with recurrent gynecological cancer based on changes in HRV
To develop and validate an algorithm to predict QOL from time-series data of individual HRV
To develop and validate a new scale to assess fatigue, depression and general health from HRV and lifelogs
To conduct a qualitative study of the patient burden of reporting daily PRO and recording the lifelog once a day
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
The percentage of agreement between changes in HRV and adverse events during chemotherapy in patients with primary gynecological cancer
Key secondary outcomes
Development, reliability and validation of Daily PRO
The percentage of agreement between changes in HRV and adverse events during chemotherapy in patients with recurrent gynecological cancer
The percentage of correct responses of QOL prediction algorithms developed using time-series data of individual HRV
Reliability and validity of a novel scale to assess fatigue, depression and general health from HRV and lifelogs
Qualitative study of the patient burden of reporting daily PRO and recording the lifelog once a day
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
| 90 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) Patients with gynecological cancer
(2) Patients who have undergone surgery for primary gynecological cancer and are expected to receive chemotherapy.
(3) Patients who are expected to receive chemotherapy for recurrent gynecological cancer and who have not received non-surgical treatment for the disease within the previous six months.
(4) 18 years of age or older
(5) Patients who have a smartphone and are able to use mobile applications.
(6) Patients who have given written consent to participate in the study.
Key exclusion criteria
(1) Patients with primary disease who have already undergone surgery, chemotherapy or radiation for the disease
(2) Patients with recurrent disease who have received surgery, chemotherapy, or radiation for the disease within the previous 6 months
(3) Patients who have received treatment for other malignancies within the previous 6 months
(4) Patients with metastatic cancer
(5) Patients who are unable to use mobile applications even with assistance
(6) Patients who are considered ineligible by their physician, whose consent has not been obtained, and who have offered to withdraw their consent
Target sample size
310
Research contact person
Name of lead principal investigator
| 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
Kawaharacho 51, Shogoin, Sakyo-ku, Kyoto city
TEL
0757513269
soulken@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Nozomi |
| Middle name | |
| Last name | Higashiyama |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of gynecology and obstetrics
Zip code
606-8507
Address
Kawaharacho 51, Shogoin, Sakyo-ku, Kyoto city
TEL
0757513269
Homepage URL
nozomi28@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Japanese Gynecologic Oncology Group
Institute
Department
Personal name
Funding Source
Organization
Japanese Gynecologic Oncology Group
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
JGOG
Address
Komatsu building 4F, Kagurazaka 6-22, Shinjyuku-ku, Tokyo-to
Tel
03-5206-1982
info@jgog.gr.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
婦人科悪性腫瘍研究機構
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 06 | Month | 30 | 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
Preinitiation
Date of protocol fixation
| 2024 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 10 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 30 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
N/A
Management information
Registered date
| 2024 | Year | 05 | Month | 22 | Day |
Last modified on
| 2024 | Year | 05 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062099
