UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046418 |
|---|---|
| Receipt number | R000052267 |
| Scientific Title | Registry Study of Immune-Related Adverse Events using ePRO in Cancer Patients Receiving Immune Checkpoint Inhibitors |
| Date of disclosure of the study information | 2021/12/20 |
| Last modified on | 2023/11/05 17:43:31 |
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Basic information
Public title
Registry Study of Immune-Related Adverse Events using ePRO in Cancer Patients Receiving Immune Checkpoint Inhibitors
Acronym
RESPECT study
Scientific Title
Registry Study of Immune-Related Adverse Events using ePRO in Cancer Patients Receiving Immune Checkpoint Inhibitors
Scientific Title:Acronym
RESPECT study
Region
| Japan |
Condition
Condition
Lung cancer,Malignant pleural mesothelioma,Gastrointestinal cancer
Classification by specialty
| Hematology and clinical oncology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to obtain a database for descriptive studies on the actual status of immune-related adverse events, focusing on symptom-related adverse events, in cancer patients treated with regimens including immune checkpoint inhibitors. We also aim to determine the incidence of symptom-related adverse events at each time point in an environment where adverse event monitoring using electronic Patient Reported Outcome (ePRO) is implemented in daily practice.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The purpose of this study is to obtain a database for descriptive studies on the actual status of immune-related adverse events, focusing on symptom-related adverse events, in cancer patients treated with regimens including immune checkpoint inhibitors.
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.diagnosed with lung cancer, malignant pleural mesothelioma, gastrointestinal cancer
2.patients scheduled to be treated with immune checkpoint inhibitors
3.20 years or older
4.Eastern Cooperative Oncology Group performance status of 0 -3
5.patients who can give written consent to participate in the study.
Key exclusion criteria
1.does not have a device that can be used with ePRO
2.severe psychiatric disorder
3.cognitive impairment that may affect the completion of the questionnaire
4.native language is not Japanese
Target sample size
260
Research contact person
Name of lead principal investigator
| 1st name | atsushi |
| Middle name | |
| Last name | sofuni |
Organization
Tokyo Medical University Hospital
Division name
Department of Clinical Oncology
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
a-sofuni@amy.hi-ho.ne.jp
Public contact
Name of contact person
| 1st name | kanako |
| Middle name | |
| Last name | azuma |
Organization
Tokyo Medical University Hospital
Division name
Department of Pharmacy
Zip code
160-0023
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
TEL
03-3342-6111
Homepage URL
azuma-k@tokyo-med.ac.jp
Sponsor or person
Institute
MHLW(Japan)
Institute
Department
Personal name
Funding Source
Organization
MHLW(Japan)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tokyo Medical University
Address
6-7-1 Nishishinjuku, Shinjuku-ku, Tokyo
Tel
03-3342-6111
IRB@tokyo-med.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 | 12 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 10 | Month | 15 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 15 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2026 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Once the patient installs and registers a dedicated application for adverse event reporting on their smartphone or tablet, the survey will be distributed to the application at defined times thereafter. Adverse events entered by patients can be viewed by researchers and healthcare providers in the 3H medical system. There is no provision for viewing the entered information or for medical intervention based on the viewing of the information, as this is similar to reviewing the patient diary and responding as necessary.
Management information
Registered date
| 2021 | Year | 12 | Month | 20 | Day |
Last modified on
| 2023 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052267
