UMIN-CTR Clinical Trial

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