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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000040922
Receipt No. R000046727
Scientific Title Health-related quality of life in patients with metastatic renal cell carcinoma treated with tyrosine kinase inhibitors and immunotherapy: A prospective observational study (PROmRCC study)
Date of disclosure of the study information 2020/06/30
Last modified on 2020/07/02

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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: A prospective observational study (PROmRCC study)
Acronym Health-related quality of life in patients with metastatic renal cell carcinoma treated with tyrosine kinase inhibitors and immunotherapy: A prospective 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: A prospective 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: A prospective 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
Email 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
Email shingorilla2@gmail.com

Sponsor
Institute Hirosaki University School of Medicine
Institute
Department

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
Email 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
2020 Year 07 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046727

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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