UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040922 |
|---|---|
| Receipt number | R000046727 |
| Scientific Title | Health-related quality of life in patients with metastatic renal cell carcinoma treated with tyrosine kinase inhibitors and immunotherapy: An observational study (PROmRCC study) |
| Date of disclosure of the study information | 2020/06/30 |
| Last modified on | 2023/03/21 09:56:22 |
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Basic information
Public title
Health-related quality of life in patients with metastatic renal cell carcinoma treated with tyrosine kinase inhibitors and immunotherapy: An observational study (PROmRCC study)
Acronym
Health-related quality of life in patients with metastatic renal cell carcinoma treated with tyrosine kinase inhibitors and immunotherapy: An observational study (PROmRCC study)
Scientific Title
Health-related quality of life in patients with metastatic renal cell carcinoma treated with tyrosine kinase inhibitors and immunotherapy: An observational study (PROmRCC study)
Scientific Title:Acronym
Health-related quality of life in patients with metastatic renal cell carcinoma treated with tyrosine kinase inhibitors and immunotherapy: An observational study (PROmRCC study)
Region
| Japan |
Condition
Condition
Renal cell carcinoma
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The objective was to assess whether first-line immunotherapy improved HRQoL in mRCC patients as well as the effect of irAEs on HRQoL of those patients.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary objective was to compare the HRQoL difference between the baseline and three months after treatment.
Key secondary outcomes
The secondary objective was to compare the HRQoL between patients with and without severe (grade 3 or higher) irAEs.
The exploratory objective was to compare the HRQoL between patients treated with immunotherapy as well as TKIs three months after treatment.
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Inclusion criteria was mRCC patients (1) who had the IMDC intermediate- or poor-risk disease, (2) who were able to answer QoL questionnaire, and (3) without active autoimmune disease.
Key exclusion criteria
Exclusion criteria were mRCC patients (1) who had the IMDC favorable-risk disease, (2) who were not able to answer QoL questionnaire, and (3) who were not feasible for immunotherapy.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | Hatakeyama |
| Last name | Hatakeyama |
Organization
Hirosaki University School of Medicine
Division name
Urology
Zip code
036-8562
Address
Hirosaki
TEL
0172395091
shingoh@hirosaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Hatakeyama |
Organization
Dept. of Urology, Hirosaki University Graduate School of Medicine
Division name
Urology
Zip code
036-8562
Address
Hirosaki
TEL
0172395091
Homepage URL
shingorilla2@gmail.com
Sponsor or person
Institute
Hirosaki University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Hirosaki University School of Medicine
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
Hirosaki University School of Medicine
Address
Hirosaki
Tel
0172395091
rinri@hirosaki-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
| 2020 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 02 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This multicenter observational study was conducted in accordance with the ethical standards of the Declaration of Helsinki and approved by the Ethics Committee of Hirosaki University School of Medicine.
HRQoL was assessed under the European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 instruments. Analyzed HRQoL items included functioning summary QoL (physical, role, cognitive, emotional, and social), symptom summary QoL (nausea or vomiting, appetite loss, constipation, diarrhea, pain, or fatigue, dyspnea, and sleep), and global QoL. Since the symptom summary QoL represents a higher value as the worse outcome, we used [100-symptom summary QoL] in some analyses to represent a higher value as a better outcome.
Management information
Registered date
| 2020 | Year | 06 | Month | 28 | Day |
Last modified on
| 2023 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046727
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