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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000037433
Receipt No. 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 2020/07/20

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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
Email 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
Email holt802@ybb.ne.jp

Sponsor
Institute St.Marianna University School of Medicine
Institute
Department

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
Email 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 Enrolling by invitation
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
2020 Year 07 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042209

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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