UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041413 |
|---|---|
| Receipt number | R000047282 |
| Scientific Title | Exploratory Study on Companion/Complimentary Diagnosis Platforms for Immune Checkpoint Inhibitor Treatment of Urothelial Cancer Based on Plasma Cell-free DNA |
| Date of disclosure of the study information | 2020/09/01 |
| Last modified on | 2025/02/18 19:10:12 |
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Basic information
Public title
Exploratory Study on Companion/Complimentary Diagnosis Platforms for Immune Checkpoint Inhibitor Treatment of Urothelial Cancer Based on Plasma Cell-free DNA
Acronym
cfDNA diagnostics for urothelial cancer
Scientific Title
Exploratory Study on Companion/Complimentary Diagnosis Platforms for Immune Checkpoint Inhibitor Treatment of Urothelial Cancer Based on Plasma Cell-free DNA
Scientific Title:Acronym
cfDNA diagnostics for urothelial cancer
Region
| Japan |
Condition
Condition
Urothelial cancer
Classification by specialty
| Urology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
Preliminary analysis and feasibility verification of for the development of cfDNA-based platforms focused on the concordance with gene mutation profile, TMB, gene expression profile, immunohistological findings obtained from urothelial cancer tissue.
Basic objectives2
Others
Basic objectives -Others
Observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concordance index of tumor somatic mutation profile based on cfDNA sequence for gene mutation profile, TMB, gene expression profile, immunohistological findings based on tumor tissue.
Key secondary outcomes
Predictive values of tumor somatic mutation profile based on cfDNA sequence for patient prognosis and treatment response.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Urothelial cancer patients who have consented to the secondary use of specimens and have both tumor tissue and blood specimens preserved since 2018.
Key exclusion criteria
Those who did not give a consent for the secondary use of the sample. Those who opted out the refusal to participate this research.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Kobayashi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Urology
Zip code
606-8507
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3326
selecao@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Kobayashi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Urology
Zip code
606-8507
Address
54 Shogoinkawahara-cho, Sakyo-ku, Kyoto, Japan
TEL
075-751-3326
Homepage URL
selecao@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Chugai Pharmaceutical Co., Ltd.
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshidakonoe-cho, Sakyo-ku, Kyoto, Japan
Tel
075-753-4680
ethcom@kuhp.kyoto-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 | 09 | Month | 01 | Day |
Related information
URL releasing protocol
https://www.urology.kuhp.kyoto-u.ac.jp/information/research_activities.html
Publication of results
Published
Result
URL related to results and publications
https://ascopubs.org/doi/10.1200/PO-24-00472
Number of participants that the trial has enrolled
82
Results
1. Among the 82 study participants, 43.7% had distant metastases, and their ctDNA fraction was elevated (median: 4.86%). Genetic mutations were identified in tumor tissue samples from 64 cases, with a concordance rate of 50.2% between tumor tissue and cfDNA.
2. A higher ctDNA fraction was significantly associated with the presence of distant metastases (P = 0.012). Additionally, in samples with a ctDNA fraction of 5% or higher, the concordance rate with tumor tissue samples was 89.7%.
Results date posted
| 2025 | Year | 02 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with nonmetastatic muscle- invasive or metastatic urothelial cancer.
Participant flow
Selection Criteria for Study Participants
1. Setting
Patients diagnosed with urothelial carcinoma based on clinical and pathological evaluation who received treatment at Kyoto University Hospital between January 1, 2018, and October 31, 2020. Eligible patients must have had blood and tumor samples collected as part of the study "Personalized Treatment Approaches in Urological Cancer" (Research Project Number: G-52) and must have provided written consent for the secondary use of their specimens.
2. Eligibility Criteria
Inclusion Criteria
Patients who meet the following criteria are eligible for this study:
Provided informed consent for participation in the study "Personalized Treatment Approaches in Urological Cancer" (Research Project Number: G-52) conducted by the Department of Urology, Graduate School of Medicine, Kyoto University.
Provided consent for the secondary use of specimens in accordance with Kyoto University Hospital's "Explanation and Consent Form for the Storage and Future Use of Biological Samples."
Both tumor tissue and blood samples must have been preserved since 2018.
The selection criteria for the G-52 study include:
Patients with a pathological diagnosis of urological cancer.
Other participants, including patients diagnosed with benign urological diseases and healthy individuals who attended urology outpatient services (control group). The control group is essential for analyzing genetic marker changes associated with the therapeutic efficacy of urothelial carcinoma treatment. When collecting specimens from these control participants, thorough explanations and consent are required.
For this study, only patients falling under the first category those diagnosed with urothelial carcinoma will be included.
Exclusion Criteria
Patients will be excluded if they:
Did not provide consent for the secondary use of specimens as part of the "Personalized Treatment Approaches in Urological Cancer" study (Research Project Number: G-52) or Kyoto University Hospital's "Explanation and Consent Form for the Storage and Future Use of Biological Samples."
Expressed their intention to opt out of this study.
Adverse events
No adverse events
Outcome measures
We identified genetic mutations from cfDNA and evaluated various parameters, including variant allele frequency (VAF), ctDNA fraction, and tumor mutation burden (TMB).
We analyzed the dynamics of the cancer cell fraction (CCF), which was calculated based on the VAF of detected genetic mutations during systemic therapy and upon the emergence of resistance.
Furthermore, we examined the association between cfDNA analysis results and clinical outcomes, including treatment response rate, progression-free survival, and overall survival.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 26 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study on cfDNA-based diagnostics in urothelial carcinoma
Management information
Registered date
| 2020 | Year | 08 | Month | 14 | Day |
Last modified on
| 2025 | Year | 02 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047282
