UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043018 |
|---|---|
| Receipt number | 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 15:41:39 |
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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
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
masaharu.okamoto@iqvia.com
Sponsor or person
Institute
MSD K.K.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049111
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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