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Renal Cell Carcinoma Microenvironment Discovery Project (REMEDY)
| 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 |
| 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 |
| Group/Cohort |
|---|
|
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.
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- 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
| 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 |
Inclusion Criteria:
- Nephrectomy
- Primary or metastatic disease
- Any histology
Exclusion Criteria:
- NA
| Contact: Antonio Finelli, MD | 416-946-2851 | antonio.finelli@uhn.ca | |
| Contact: Keith Lawson, MD | 416-400-9185 | keith.lawson6@gmail.com |
| 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 | |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | May 20, 2019 | ||||||||
| First Posted Date | July 2, 2019 | ||||||||
| Last Update Posted Date | September 2, 2020 | ||||||||
| Actual Study Start Date | May 6, 2019 | ||||||||
| Estimated Primary Completion Date | May 1, 2030 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
|
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures | Not Provided | ||||||||
| Original Secondary Outcome Measures | Not Provided | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Renal Cell Carcinoma Microenvironment Discovery Project | ||||||||
| Official Title | Molecular Dissection of the Renal Cell Carcinoma Tumor Microenvironment for the Discovery of Novel Therapeutic Targets | ||||||||
| 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. | ||||||||
| 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 | ||||||||
| Study Design | Observational Model: Other Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples With DNA Description:
Biopsy, surgically resected tumour specimen, blood, urine
|
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| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Primary care clinic Renal cell carcinoma undergoing surgery | ||||||||
| Condition | Renal Cell Carcinoma | ||||||||
| Intervention | Not Provided | ||||||||
| Study Groups/Cohorts | 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.
|
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
300 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | July 1, 2030 | ||||||||
| Estimated Primary Completion Date | May 1, 2030 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | Canada | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT04005183 | ||||||||
| Other Study ID Numbers | 17-5204 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | University Health Network, Toronto | ||||||||
| Study Sponsor | University Health Network, Toronto | ||||||||
| Collaborators | Celsus Therapeutics PLC | ||||||||
| Investigators | Not Provided | ||||||||
| PRS Account | University Health Network, Toronto | ||||||||
| Verification Date | September 2020 | ||||||||
