TRACERx Renal (TRAcking Renal Cell Carcinoma Evolution Through Therapy (Rx)) (TRACERxRenal)
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| ClinicalTrials.gov Identifier: NCT03226886 |
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Recruitment Status :
Recruiting
First Posted : July 24, 2017
Last Update Posted : September 23, 2019
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| Condition or disease |
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| Renal Cell Carcinoma |
There is a need for improved understanding of renal cell carcinoma (RCC) biology in order to characterise the mechanisms of metastatic progression, drug resistance, develop predictive & prognostic biomarkers and to identify novel therapeutic targets for this disease. The TRACERx consortium was established to achieve this using large longitudinal clinical studies, in collaboration with laboratory, advanced sequencing and informatics expertise to identify the relationships between intratumour heterogeneity and clinical outcome.
Response and Resistance: TRACERx Renal is a prospective longitudinal cohort study. It will draw on the methodology already being used within the TRACERx Lung & (planned) Breast studies as part of the TRACERx consortium.
Primary Endpoint
• To calculate the proportion of patients who are in possession of a mutation in a gene of interest
The Investigators expect to collect 360 specimens by 2018 at an ongoing rate of approximately 60 per year.
The Investigators plan to collect the following biological samples:
- Blood sample/s, urine and tumour biopsy tissue taken prior to any neoadjuvant treatment that might be administered.
- Blood sample/s, urine and tumour biopsy tissue taken prior to any ablative procedure
- Blood sample/s, urine and nephrectomy tissue taken at the time of nephrectomy.
- Blood sample/s, urine and tumour tissue taken at the time of palliative metastasectomy/surgery.
- Blood and urine sample/s taken at routine follow up.
- Blood sample/s, urine and tumour biopsy taken at time of disease progression.
- Blood sample/s and/or archival tissue specimens that are no longer required by the local pathologist for diagnostic purposes
- Blood sample/s and/or archival tissue specimens that are no longer required by the local pathologist for diagnostic purposes from study patient family members
| Study Type : | Observational |
| Estimated Enrollment : | 360 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | TRACERx Renal (TRAcking Renal Cell Carcinoma Evolution Through Therapy (Rx)) |
| Actual Study Start Date : | February 5, 2012 |
| Estimated Primary Completion Date : | September 1, 2023 |
| Estimated Study Completion Date : | September 1, 2023 |
| Group/Cohort |
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All patients
In London renal cell carcinoma patients undergo nephrectomy at centres for urological oncology, including the Royal Marsden, Guy's and St Thomas', St Georges, Charing Cross and Kings Hospitals. It is not uncommon for the same patients to undergo palliative resection for metastatic sites of disease. The majority of tissue from these resections does not undergo routine histopathological examination. As such, it is ethically feasible to use these specimens for laboratory research in the presence of patient consent. Practically, these specimens are often large, thereby offering considerable scope for a range of molecular analyses.
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- To calculate the proportion of patients who are in possession of a mutation in a gene of interest [ Time Frame: From trial activation until trial closure approximately 1st September 2023 ]Outcomes will be quantified using descriptive statistics with the intention of providing hypothesis-generating data for use in future studies.
Biospecimen Retention: Samples With DNA
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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 |
Inclusion Criteria:
- Age 18- years or older
- Patients with histopathologically confirmed renal cell carcinoma, or suspected renal cell carcinoma, proceeding to neoadjuvant therapy and/or nephrectomy/metastasectomy, or identified as having progressive disease
- Or in patients undergoing nephrectomy for non-malignant disease
- Medical and/or surgical management in accordance with national and/or local guidelines
- Written informed consent
Exclusion Criteria:
- Any concomitant medical or psychiatric problems which, in the opinion of the investigator, would prevent completion of treatment or follow-up
- Lack of adequate tissue
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 ClinicalTrials.gov identifier (NCT number): NCT03226886
| Contact: Samra Turajlic | 0207 811 8576 | Samra.Turajlic@crick.ac.uk | |
| Contact: Ellie Carlyle | 0207 808 2752 | eleanor.carlyle@rmh.nhs.uk |
| United Kingdom | |
| Edinburgh Western General Hospital | Recruiting |
| Edinburgh, Scotland, United Kingdom, EH4 2XU | |
| Contact: Steve Leung steve.leung@nhs.net | |
| Guy's & St Thomas Hospital | Recruiting |
| London, UK, United Kingdom, SE1 9RT | |
| Contact: Dr Simon Chowdhury 02071887188 Simon.Chowdhury@gstt.nhs.uk | |
| Contact: Sharanpreet Lall 020 7188 2007 sharanpreet.lall@kcl.ac.uk | |
| Royal Free Hospital | Recruiting |
| London, United Kingdom, NW3 2QC | |
| Contact: Dr Michael Aitchinson michael.aitchison@nhs.net | |
| Principal Investigator: | Samra Turajlic | Royal Marsden NHS Foundation Trust |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Royal Marsden NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT03226886 |
| Other Study ID Numbers: |
CCR 3723 |
| First Posted: | July 24, 2017 Key Record Dates |
| Last Update Posted: | September 23, 2019 |
| Last Verified: | September 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Plan Description: | Patients are given a unique identifier as soon as they are consented. All samples and data is anonymised and can only be accessed by the research team. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Carcinoma Carcinoma, Renal Cell Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma |
Kidney Neoplasms Urologic Neoplasms Urogenital Neoplasms Neoplasms by Site Kidney Diseases Urologic Diseases |