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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043018
Receipt No. R000049111
Scientific Title Treatment patterns, outcomes and health care resource utilisation in patients with metastatic renal cell carcinoma (RCC)
Date of disclosure of the study information 2021/01/18
Last modified on 2021/01/15

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Basic information
Public title Treatment patterns, outcomes and health care resource utilisation in patients with metastatic renal cell carcinoma (RCC)
Acronym POEM
Scientific Title Treatment patterns, outcomes and health care resource utilisation in patients with metastatic renal cell carcinoma (RCC)
Scientific Title:Acronym POEM
Region
Japan

Condition
Condition Metastatic renal cell carcinoma
Classification by specialty
Urology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 1. To describe the demographic and clinical characteristics with first-line mRCC treatment
2. To describe real-world treatment patterns and sequence of regimens for mRCC by line of therapy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Real-World Treatment Patterns
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 a.Patients with mRCC diagnosis histologically or clinically confirmed prior to starting systemic anti-cancer therapy such as 1L line, pembrolizumab/axitinib, avelumab/axitinib, nivolumab/ipilimumab, sunitinib, pazopanib, cabozantinib, sorafenib, IFN, low dose IL-2, temsirolimus.
b.Patients who start 1L systemic anti-cancer treatment for mRCC at a participating centre between Q4 2020 and Q4 2023. In addition to patients presenting with de novo metastatic disease, this will also include patients who were diagnosed at an earlier stage of disease and who will start 1L treatment for mRCC after recurrence or progression.
c.Patient who have data on International Metastatic RCC Database Consortium (IMDC) risk classification.
d.Patient with at least 20 years of age at the time of diagnosis of mRCC.
e.Patient treated with neoadjuvant or adjuvant treatment in the non-metastatic setting are allowed in the study unless they received the treatment as clinical trials/stu
Key exclusion criteria a.Patient who have any active cancer or undergoing treatment for cancer other than mRCC
b.Patient received/about to receive 1L systemic anti-cancer treatment as a clinical trial participant.
c.Patient's last adjuvant treatment for RCC was less than 4 weeks (i.e. 28 days)
d.Investigator determined the patient to be ineligible due to incomplete medical records at the time of enrolment. Incomplete medical records might be observed for patients who recently transferred to the site without diagnosis or treatment records, or for patients who attended the site only for consultation or second opinion.
e.Patients those can be treated with curative intent through either surgical resection and/or percutaneous local therapy will be excluded.
a.Patients with transitional cell carcinoma of the renal pelvis or ureter
Target sample size 1000

Research contact person
Name of lead principal investigator
1st name Takuto
Middle name
Last name Tokudome
Organization MSD K.K.
Division name Oncology Medical Affairs
Zip code 1028667
Address KITANOMARU SQUARE, 1-13-12, Kudan-kita, Chiyoda-ku, Tokyo
TEL 03-6272-0345
Email ldgproject@merck.com

Public contact
Name of contact person
1st name Masaharu
Middle name
Last name Okamoto
Organization IQVIA Services Japan K.K.
Division name Real World Evidence Services, Real World & Analytics Soulutions
Zip code 532-0003
Address NISSAY Shin-Osaka Bldg 3-4-30, Miyahara Yodokawa-ku Osaka-shi, Osaka
TEL 080-4733-9431
Homepage URL
Email masaharu.okamoto@iqvia.com

Sponsor
Institute MSD K.K.
Institute
Department

Funding Source
Organization NA
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 National Hospital Organization Hokkaido Cancer CenterInstitutional Review Board
Address Sapporo-shi, shiraishi-ku, kikusui4jyou2-3-54
Tel 011-811-9111
Email NA

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 01 Month 18 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 Preinitiation
Date of protocol fixation
2020 Year 08 Month 24 Day
Date of IRB
Anticipated trial start date
2021 Year 01 Month 19 Day
Last follow-up date
2025 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information NA

Management information
Registered date
2021 Year 01 Month 15 Day
Last modified on
2021 Year 01 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049111

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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