Renal Cell Carcinoma Microenvironment Discovery Project (REMEDY)
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|ClinicalTrials.gov Identifier: NCT04005183|
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : September 2, 2020
|Condition or disease|
|Renal Cell Carcinoma|
This study is an observational prospective trial where renal cell carcinoma samples are isolated from nephrectomy specimens in a multi-regional manner and subjected to an integrated genomic, pathological and radiological assessment to provide a detailed morphological and molecular view of the RCC microenvironment.
The major genomics technologies used to examine tumour specimens include single cell RNA sequencing including nuclear (NUCseq) and epitope sequencing (CITEseq). Additionally, bulk RNA sequencing and targeted mutational profiling will be performed. These technologies will determine mutational and gene expression profiles of various heterogeneous cell populations within the tumour microenvironment, including cancer, immune, and supporting cells. This will allow identification of mutations and abnormal expression patterns within individual cells, that will be used to infer targetable vulnerabilities and biomarker signatures.
In addition, ex vivo tumor magnetic resonance imaging (MRI) and digital pathology will be performed on a subset of cases to facilitate correlative radio -genomic and -pathological assessment.
|Study Type :||Observational|
|Estimated Enrollment :||300 participants|
|Official Title:||Molecular Dissection of the Renal Cell Carcinoma Tumor Microenvironment for the Discovery of Novel Therapeutic Targets|
|Actual Study Start Date :||May 6, 2019|
|Estimated Primary Completion Date :||May 1, 2030|
|Estimated Study Completion Date :||July 1, 2030|
Patients undergoing nephrectomy at the University Health Network are eligible for enrolment. All histological subtypes and stages are eligible. Tumor, blood and urine samples are acquired at the time of nephrectomy.
- Molecular profiling of various cell populations within tumour by using single cell RNA-CITEseq. [ Time Frame: 10 years ]The RNA transcripts of tumour cells will be sequenced and subjected to informatics and descriptive statistical methods to generate comprehensive data sets that aid in better understanding of the tumour microenvironment in various patients and disease types. These data sets will provide insights into drug target discovery, and used as hypothesis-generating guidance for future study aims.
- Determination of the radiological and pathological features associated with the derived tumor microenvironment molecular data [ Time Frame: 10 years ]The radiological and pathological assessment on each tumour case will be paired with the gene- and protein-level data to provide a comprehensive picture of the disease. These datasets will be used as training sets to guide machine learning technologies with the intention of aiding diagnosis, prognosis prediction, and treatment plans in the future.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04005183
|Contact: Antonio Finelli, MDfirstname.lastname@example.org|
|Contact: Keith Lawson, MDemail@example.com|
|University Health Network, Princess Margaret Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 2M9|
|Contact: Antonio Finelli, MD|
|Principal Investigator: Antonio Finelli, MD MSc FRCSC|