Renal Cell Carcinoma Microenvironment Discovery Project (REMEDY)

July 25, 2023 updated by: University Health Network, Toronto

Molecular Dissection of the Renal Cell Carcinoma Tumor Microenvironment for the Discovery of Novel Therapeutic Targets

This study will obtain tumor samples from nephrectomy specimens in a multi-regional fashion and subject them to integrated genomics, proteomics, 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.

Study Overview

Status

Active, not recruiting

Conditions

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, proteomic, pathological, 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/DNA sequencing, targeted mutational profiling, and imaging mass cytometry will be performed. These technologies will determine mutational and gene/protein 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.

Study Type

Observational

Enrollment (Estimated)

350

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network, Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic Renal cell carcinoma undergoing surgery

Description

Inclusion Criteria:

  • Nephrectomy
  • Primary or metastatic disease
  • Any histology of renal cell carcinoma

Exclusion Criteria:

  • NA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
All patients
Patients undergoing nephrectomy at the University Health Network are eligible for enrolment. All renal cell carcinoma histological subtypes and stages are eligible. Tumor, blood and urine samples are acquired at the time of nephrectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Molecular profiling of various cell populations within tumour by using single cell RNAseq.
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.
10 years
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.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Celsius Therapeutics

Investigators

  • Principal Investigator: Antonio Finelli, MD, University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 6, 2019

Primary Completion (Actual)

July 20, 2023

Study Completion (Estimated)

July 1, 2030

Study Registration Dates

First Submitted

May 20, 2019

First Submitted That Met QC Criteria

June 28, 2019

First Posted (Actual)

July 2, 2019

Study Record Updates

Last Update Posted (Actual)

July 28, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17-5204

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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