UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037433 |
|---|---|
| Receipt number | R000042209 |
| Scientific Title | An observational study of symptomatic adverse events and health-related quality of life (HR-QoL) with the use of patient-reported outcome (PRO) in nivolumab therapy for gastric cancer |
| Date of disclosure of the study information | 2019/07/20 |
| Last modified on | 2023/01/28 16:26:53 |
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Basic information
Public title
An observational study of symptomatic adverse events and health-related quality of life (HR-QoL) with the use of patient-reported outcome (PRO) in nivolumab therapy for gastric cancer
Acronym
NIVO-G QoL Study
Scientific Title
An observational study of symptomatic adverse events and health-related quality of life (HR-QoL) with the use of patient-reported outcome (PRO) in nivolumab therapy for gastric cancer
Scientific Title:Acronym
NIVO-G QoL Study
Region
| Japan |
Condition
Condition
gastric cancer
Classification by specialty
| Gastroenterology | Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This prospective observational study will be conducted in gastric cancer patients who receive nivolumab therapy in actual clinical settings in Japan, in order to evaluate the effects of adverse events on a reduction in the HR-QoL of patients during treatment by collecting information on symptomatic adverse events and HR-QoL out-of-hospital via electronic patient reported outcome (ePRO).
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effect of adverse events on a reduction in QoL
Key secondary outcomes
Adverse events at baseline and at 12 weeks of treatment (physician's and patient's assessments).
QoL at baseline and at 12 weeks of treatment.
Concordance between physician's assessment (NCI-CTCAE, ver.4.0) and patient's assessment (PRO-CTCAE, ver.1.0).
Patient's compliance with ePRO entry (e.g., at 4, 8, and 12 weeks).
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
| 99 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Major Inclusion Criteria:
1. Patients with a pathologically (histologically) confirmed diagnosis of gastric cancer who will be treated with the immune checkpoint inhibitor nivolumab (regardless of line of treatment)
2. Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
3. Patients at least 20 years of age at the time of informed consent
4. The presence or absence of measurable lesions or evaluable lesions does not matter as an inclusion criterion.
5. Patients who can use an electronic device which can connect to the Internet, at home (including smartphones, tablets, and personal computers).
6. Patients who are scheduled to receive outpatient treatment at the same hospital for at least 3 months.
Key exclusion criteria
Major Exclusion Criteria:
1. Patients who meet any of the following exclusion criteria will be excluded from this study:
2. Patients who concurrently participate in another detailed PRO study.
3. Patients who apparently have difficulty in evaluating their symptoms by themselves due to a mental condition or cognitive impairment.
4. Patients who apparently have difficulty in using an electronic device for data entry due to a physical disability
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | TAKAKO |
| Middle name | |
| Last name | NAKAJIMA |
Organization
Kyoto University Hospital
Division name
Kyoto Innovation Center for Next Generation Clinical Trials and iPS Cell Therapy (Ki-CONNECT)
Zip code
606-8507
Address
54 Kawaharacho, Shogoin, Sakyo-ku Kyoto
TEL
075-751-4732
tnakajima@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | YOSHIKI |
| Middle name | |
| Last name | HORIE |
Organization
St.Marianna University School of Medicine
Division name
Department of Clinical Oncology
Zip code
216-8511
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
TEL
044-977-8111
Homepage URL
holt802@ybb.ne.jp
Sponsor or person
Institute
St.Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Bristol-Myers Squibb
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
St.Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawasaki, Kanagawa
Tel
044-977-8111
holt802@ybb.ne.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
| 2019 | Year | 07 | Month | 20 | 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
Main results already published
Date of protocol fixation
| 2018 | Year | 12 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 21 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 29 | Day |
Last follow-up date
| 2021 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study on adverse events and QOL during nivolumab monotherapy for patients with gastric cancer using ePRO system.
Management information
Registered date
| 2019 | Year | 07 | Month | 20 | Day |
Last modified on
| 2023 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042209
