Clinical trial NCT04005183: Renal Cell Carcinoma Microenvironment Discovery Project
Official title: Molecular Dissection of the Renal Cell Carcinoma Tumor Microenvironment for the Discovery of Novel Therapeutic Targets
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Keywords: Renal Cell Carcinoma
Genomics
Single-cell
Microenvironment
Immunotherapy
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Kidney Diseases
Urologic Diseases
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Celsius Therapeutics, Inc.
First posted: 2019-07-02
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic Renal cell carcinoma undergoing surgery

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* NA

Primary outcomes:
measure: Molecular profiling of various cell populations within tumour by using single cell RNAseq.
timeFrame: 10 years
measure: Determination of the radiological and pathological features associated with the derived tumor microenvironment molecular data
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network, Princess Margaret Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Antonio Finelli, MD
role: PRINCIPAL_INVESTIGATOR
References: