Renal Cell CarcinomaREMEDYNCT04005183
Renal Cell Carcinoma Microenvironment Discovery Project
An observational study of Renal Cell Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma
- How many people
- 146 participants
- Where
- 1 siteCanada
- Study dates
- 6 May 2019to 20 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic Renal cell carcinoma undergoing surgery
Who may be able to join
- Nephrectomy
- Primary or metastatic disease
- Any histology of renal cell carcinoma
Who cannot join
- NA
Trial locations and contacts
1 site in 1 country.
Canada1 site
University Health Network, Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
About this study
Official title: 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.
Read the 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.
- 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
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Kidney Neoplasms, Urologic Neoplasms, Urogenital Neoplasms, Neoplasms by Site, Kidney Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Molecular profiling of various cell populations within tumour by using single cell RNAseq.
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.
Measured: 10 years
Determination of the radiological and pathological features associated with the derived tumor microenvironment molecular data
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.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2019
- Study start6 May 2019
- Primary completion20 Jul 2023
- Study completion20 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Celsius Therapeutics, Inc.
- Responsible party
- Sponsor
- Investigators
- Antonio Finelli, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04005183
- Sponsor's protocol ID
- 17-5204
- Acronym
- REMEDY
- Status last verified
- Oct 2024
- First submitted
- 20 May 2019
- Last updated
- 10 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular Dissection of the Renal Cell Carcinoma Tumor Microenvironment for the Discovery of Novel Therapeutic Targets
- ClinicalTrials.gov ID
- NCT04005183
- Acronym / sponsor ID
- REMEDY / 17-5204
- Conditions
- Renal Cell Carcinoma
- Keywords
- Renal Cell Carcinoma, Genomics, Single-cell, Microenvironment, Immunotherapy, Neoplasms, Glandular and Epithelial, Neoplasms by Histologic Type, Kidney Neoplasms
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Celsius Therapeutics, Inc.
- Study start
- 6 May 2019 (actual)
- Primary completion
- 20 Jul 2023 (actual)
- Study completion
- 20 Jul 2023 (actual)
- First posted
- 2 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic Renal cell carcinoma undergoing surgery
Key inclusion criteria (3 listed)
- Nephrectomy
- Primary or metastatic disease
- Any histology of renal cell carcinoma
Key exclusion criteria (1 listed)
- NA
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Antonio Finelli, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Molecular profiling of various cell populations within tumour by using single cell RNAseq. (time frame: 10 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Oct 2024.