TRACERx Renal CAPTURE Sub-study (TRACERxRenal)
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ClinicalTrials.gov Identifier: NCT03226886 |
Recruitment Status :
Recruiting
First Posted : July 24, 2017
Last Update Posted : August 25, 2020
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TRACERx Renal: This is a translational study, which, aims to develop prognostic and predictive biomarkers for patients with renal cell carcinoma (RCC).
CAPTURE Sub-study: Covid-19 antiviral response in a pan-tumour immune monitoring study
Condition or disease |
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Renal Cell Carcinoma Cancer Healthy Volunteers |

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)) CAPTURE: COVID-19 Antiviral Response in a Pan-tumour Immune Study |
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. CAPTURE Sub-study: We plan to enrol patients/participants into three groups: Group A: patients with confirmed or suspected COVID-19 and a history of cancer Group B: patients without a history of COVID-19 infection and a history of cancer Group C: Hospital staff with or without a history of COVID-19 |
- To validate ITH index and WGII as stage and grade independent prognostic markers of progression free survival in patients with ccRCC 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.
- CAPTURE Sub-study: Describe the population characteristics between SARS-CoV-2 positive and negative cancer patients [ Time Frame: From sub-study activation until trial closure approximately 2027 ]Outcomes will be quantified using descriptive statistics
Biospecimen Retention: Samples With DNA
TRACERx Renal: The Investigators will be collecting Blood, Urine, Core Biopsies and Surgical Samples
CAPTURE Sub-study: The Investigators will be collecting Bloods, Swabs and stored samples from patients and Health Care Workers

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
TRACERx Renal: Patients with histopathologically confirmed renal cell carcinoma, or suspected renal cell carcinoma, proceeding to neoadjuvant therapy and/or nephrectomy/metastectomy, or identified as having progressive disease or in patients undergoing nephrectomy for non-malignant disease
CAPTURE:
Group A : Cancer patients with SARS-CoV-2 Group B : Cancer patients without clinical indication for SARS-CoV-2 testing (based on current local guidelines) or have tested negative for SARS-CoV-2 Group C: Volunteers without cancer (recruiting site staff)
TRACERx Renal 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
CAPTURE Inclusion criteria
- Documented informed consent
- Age 18 years or older
- Confirmed cancer diagnosis (irrespective of cancer type, disease burden or treatment)
- Group A: Suspected infection with SARS-CoV-2 or positive test for SARS-CoV-2
- Group B: no clinical indication to test for SARS-CoV-2 (by current Trust guidelines*) or tested negative for SARS-CoV-2
- Group C: Volunteers without cancer with SARS-CoV-2 (symptomatic and asymptomatic) and those without clinical indication (current national guidelines*) for SARS-CoV-2 testing or tested negative for SARS-CoV-2
Exclusion criteria
• Medical or psychological condition that would preclude informed consent

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 | |
Guy's & St Thomas Hospital | Recruiting |
London, UK, United Kingdom, SE1 9RT | |
Contact: Dr Sarah Rudman | |
Barts Health NHS Trust | Recruiting |
London, United Kingdom, E1 2EF | |
Contact: Prof William Drake | |
Royal Free Hospital | Recruiting |
London, United Kingdom, NW3 2QC | |
Contact: Dr Maxine Tran |
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: | August 25, 2020 |
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 |
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 |