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Renal Cell Carcinoma Microenvironment Discovery Project (REMEDY)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04005183
Recruitment Status : Recruiting
First Posted : July 2, 2019
Last Update Posted : September 2, 2020
Celsus Therapeutics PLC
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:
This study will obtain tumor samples from nephrectomy specimens in a multi-regional fashion and subject them to integrated genomics, pathological and radiological assessment. The goal is to better understand the the molecular basis for how various cells within the tumor microenvironment act in a coordinated manner to facilitate tumor progression and therapy resistance. Our ultimate aim is to leverage this data resource to identify novel therapeutic targets and biomarkers to improve the clinical management of this disease.

Condition or disease
Renal Cell Carcinoma

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Other
Time Perspective: Prospective
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

All patients
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.

Primary Outcome Measures :
  1. 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.

  2. 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
Biopsy, surgically resected tumour specimen, blood, urine

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Primary care clinic Renal cell carcinoma undergoing surgery

Inclusion Criteria:

  • Nephrectomy
  • Primary or metastatic disease
  • Any histology

Exclusion Criteria:

  • NA

Information from the National Library of Medicine

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 identifier (NCT number): NCT04005183

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Contact: Antonio Finelli, MD 416-946-2851
Contact: Keith Lawson, MD 416-400-9185

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Canada, Ontario
University Health Network, Princess Margaret Hospital Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Antonio Finelli, MD         
Contact: MD         
Principal Investigator: Antonio Finelli, MD MSc FRCSC         
Sponsors and Collaborators
University Health Network, Toronto
Celsus Therapeutics PLC
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Responsible Party: University Health Network, Toronto Identifier: NCT04005183    
Other Study ID Numbers: 17-5204
First Posted: July 2, 2019    Key Record Dates
Last Update Posted: September 2, 2020
Last Verified: September 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Health Network, Toronto:
Renal Cell Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases