Renal Cell CarcinomaTRACERxRenalNCT03226886
TRACERx Renal CAPTURE Sub-study
An observational study of Renal Cell Carcinoma and Cancer, run by Royal Marsden NHS Foundation Trust at 4 sites in United Kingdom.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Cell Carcinoma, Cancer, Healthy Volunteers
- How many people
- 360 participants
- Where
- 4 sitesUnited Kingdom
- Study dates
- 5 Feb 2012to 1 Sep 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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)
Who may be able to join
None listed.
Who cannot join
- 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)
Show all 10Show fewer
- 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
- Medical or psychological condition that would preclude informed consent
Trial locations and contacts
4 sites in 1 country.
United Kingdom4 sites, 4 recruiting
- Recruiting
Edinburgh Western General Hospital
Edinburgh, Scotland, EH4 2XU
Steve Leung
- Recruiting
Guy's & St Thomas Hospital
London, UK, SE1 9RT
Dr Sarah Rudman
- Recruiting
Barts Health NHS Trust
London, E1 2EF
Prof William Drake
- Recruiting
Royal Free Hospital
London, NW3 2QC
Dr Maxine Tran
About this study
Official title: TRACERx Renal (TRAcking Renal Cell Carcinoma Evolution Through Therapy (Rx)) CAPTURE: COVID-19 Antiviral Response in a Pan-tumour Immune Study
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
Read the detailed description
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 validate ITH index and WGII as stage and grade independent prognostic markers of progression free survival in patients with ccRCC
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
CAPTURE sub-study:
There is an urgent need to quantify the risk of COVID-19 illness in patients with cancer and to understand what impact anti-cancer treatments have on the immune system's response to the SARS-CoV-2 virus. There is also a need to understand how the pandemic impacts Health Care Workers (HCWs) who may be exposed to the virus in the course of their clinical duties and who are at risk to transmit the virus to vulnerable patients and colleagues in the asymptomatic phase of infection.
The CAPTURE study is a long-term study. We are establishing large observational cohorts with an intentionally broad inclusion of different tumour types and treatment schedules. In CAPTURE, we will enrol both patients infected and uninfected by the virus, and patients with all types of cancer (blood and solid cancers), and of all walks of the clinical journey (in remission, follow-up, having treatment or undergoing surgery). We also will enrol HCWs within the hospital from all sectors of care delivery - from nurses to doctors, administrative staff to catering staff, allied health and support workers.
The study will enrol patients/participants into three groups:
Group A: patients with confirmed or suspected COVID-19 and a history of cancer (n=200) Group B: patients without a history of COVID-19 infection and a history of cancer (n=1000) Group C: Hospital staff with or without a history of COVID-19 (n=200)
Comprehensive, longitudinal clinical annotation, participant questionnaires, meticulous and frequent sampling and long-term follow-up of these groups will allow robust and rapid insights that are urgently needed to guide clinical and workforce management.
This knowledge is required well beyond the current pandemic as cancer and SARSCo-V2 will coincide in the same patients, and especially given the uncertainty regarding the nature and duration of immunity in cancer patients who develop the illness and the effectiveness of vaccines in the cancer population. This study will provide us with detailed information on how to safely manage cancer patients by both minimising the risk of infection but maintaining their cancer treatment.
- Conditions
- Renal Cell Carcinoma, Cancer, Healthy Volunteers
- Medical subject headings
- Carcinoma, Renal Cell, Neoplasms
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 | 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Outcomes will be quantified using descriptive statistics with the intention of providing hypothesis-generating data for use in future studies.
Measured: From trial activation until trial closure approximately 1st September 2023
CAPTURE Sub-study: Describe the population characteristics between SARS-CoV-2 positive and negative cancer patients
Outcomes will be quantified using descriptive statistics
Measured: From sub-study activation until trial closure approximately 2027
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study start5 Feb 2012
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- 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
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Marsden NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Francis Crick Institute
- Responsible party
- Sponsor
- Investigators
- Samra Turajlic, Principal investigator, Royal Marsden NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03226886
- Sponsor's protocol ID
- CCR 3723
- Acronym
- TRACERxRenal
- Status last verified
- Sep 2019
- First submitted
- 6 Jul 2017
- Last updated
- 25 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
Orton MR, Hann E, Doran SJ, Shepherd STC, Ap Dafydd D, Spencer CE, Lopez JI, Albarran-Artahona V, Comito F, Warren H, Shur J, Messiou C, Larkin J, Turajlic S; TRACERx Renal Consortium; Koh DM. Interpretability of radiomics models is improved when using feature group selection strategies for predicting molecular and clinical targets in clear-cell renal cell carcinoma: insights from the TRACERx Renal study. Cancer Imaging. 2023 Aug 14;23(1):76. doi: 10.1186/s40644-023-00594-3.
PubMed 37580840Piening A, Ebert E, Khojandi N, Alspach E, Teague RM. Immune responses to SARS-CoV-2 in vaccinated patients receiving checkpoint blockade immunotherapy for cancer. Front Immunol. 2022 Dec 13;13:1022732. doi: 10.3389/fimmu.2022.1022732. eCollection 2022.
PubMed 36582225Fendler A, Shepherd STC, Au L, Wu M, Harvey R, Wilkinson KA, Schmitt AM, Tippu Z, Shum B, Farag S, Rogiers A, Carlyle E, Edmonds K, Del Rosario L, Lingard K, Mangwende M, Holt L, Ahmod H, Korteweg J, Foley T, Barber T, Emslie-Henry A, Caulfield-Lynch N, Byrne F, Deng D, Kjaer S, Song OR, Queval CJ, Kavanagh C, Wall EC, Carr EJ, Caidan S, Gavrielides M, MacRae JI, Kelly G, Peat K, Kelly D, Murra A, Kelly K, O'Flaherty M, Shea RL, Gardner G, Murray D, Popat S, Yousaf N, Jhanji S, Tatham K, Cunningham D, Van As N, Young K, Furness AJS, Pickering L, Beale R, Swanton C, Gandhi S, Gamblin S, Bauer DLV, Kassiotis G, Howell M, Nicholson E, Walker S, Wilkinson RJ, Larkin J, Turajlic S. Functional immune responses against SARS-CoV-2 variants of concern after fourth COVID-19 vaccine dose or infection in patients with blood cancer. Cell Rep Med. 2022 Oct 18;3(10):100781. doi: 10.1016/j.xcrm.2022.100781. Epub 2022 Sep 27.
PubMed 36240755Fendler A, Shepherd STC, Au L, Wilkinson KA, Wu M, Byrne F, Cerrone M, Schmitt AM, Joharatnam-Hogan N, Shum B, Tippu Z, Rzeniewicz K, Boos LA, Harvey R, Carlyle E, Edmonds K, Del Rosario L, Sarker S, Lingard K, Mangwende M, Holt L, Ahmod H, Korteweg J, Foley T, Bazin J, Gordon W, Barber T, Emslie-Henry A, Xie W, Gerard CL, Deng D, Wall EC, Agua-Doce A, Namjou S, Caidan S, Gavrielides M, MacRae JI, Kelly G, Peat K, Kelly D, Murra A, Kelly K, O'Flaherty M, Dowdie L, Ash N, Gronthoud F, Shea RL, Gardner G, Murray D, Kinnaird F, Cui W, Pascual J, Rodney S, Mencel J, Curtis O, Stephenson C, Robinson A, Oza B, Farag S, Leslie I, Rogiers A, Iyengar S, Ethell M, Messiou C, Cunningham D, Chau I, Starling N, Turner N, Welsh L, van As N, Jones RL, Droney J, Banerjee S, Tatham KC, O'Brien M, Harrington K, Bhide S, Okines A, Reid A, Young K, Furness AJS, Pickering L, Swanton C; Crick COVID-19 Consortium; Gandhi S, Gamblin S, Bauer DLV, Kassiotis G, Kumar S, Yousaf N, Jhanji S, Nicholson E, Howell M, Walker S, Wilkinson RJ, Larkin J, Turajlic S; CAPTURE Consortium. Adaptive immunity and neutralizing antibodies against SARS-CoV-2 variants of concern following vaccination in patients with cancer: the CAPTURE study. Nat Cancer. 2021 Dec;2(12):1305-1320. doi: 10.1038/s43018-021-00274-w. Epub 2021 Oct 27.
PubMed 35121899Fendler A, Shepherd STC, Au L, Wilkinson KA, Wu M, Byrne F, Cerrone M, Schmitt AM, Joharatnam-Hogan N, Shum B, Tippu Z, Rzeniewicz K, Boos LA, Harvey R, Carlyle E, Edmonds K, Del Rosario L, Sarker S, Lingard K, Mangwende M, Holt L, Ahmod H, Korteweg J, Foley T, Bazin J, Gordon W, Barber T, Emslie-Henry A, Xie W, Gerard CL, Deng D, Wall EC, Agua-Doce A, Namjou S, Caidan S, Gavrielides M, MacRae JI, Kelly G, Peat K, Kelly D, Murra A, Kelly K, O'Flaherty M, Dowdie L, Ash N, Gronthoud F, Shea RL, Gardner G, Murray D, Kinnaird F, Cui W, Pascual J, Rodney S, Mencel J, Curtis O, Stephenson C, Robinson A, Oza B, Farag S, Leslie I, Rogiers A, Iyengar S, Ethell M, Messiou C, Cunningham D, Chau I, Starling N, Turner N, Welsh L, van As N, Jones RL, Droney J, Banerjee S, Tatham KC, O'Brien M, Harrington K, Bhide S, Okines A, Reid A, Young K, Furness AJS, Pickering L, Swanton C; Crick COVID19 consortium; Gandhi S, Gamblin S, Bauer DL, Kassiotis G, Kumar S, Yousaf N, Jhanji S, Nicholson E, Howell M, Walker S, Wilkinson RJ, Larkin J, Turajlic S. Adaptive immunity and neutralizing antibodies against SARS-CoV-2 variants of concern following vaccination in patients with cancer: The CAPTURE study. Nat Cancer. 2021 Dec;2:1321-1337. doi: 10.1038/s43018-021-00274-w. Epub 2021 Oct 27.
PubMed 34950880Turajlic S, Xu H, Litchfield K, Rowan A, Chambers T, Lopez JI, Nicol D, O'Brien T, Larkin J, Horswell S, Stares M, Au L, Jamal-Hanjani M, Challacombe B, Chandra A, Hazell S, Eichler-Jonsson C, Soultati A, Chowdhury S, Rudman S, Lynch J, Fernando A, Stamp G, Nye E, Jabbar F, Spain L, Lall S, Guarch R, Falzon M, Proctor I, Pickering L, Gore M, Watkins TBK, Ward S, Stewart A, DiNatale R, Becerra MF, Reznik E, Hsieh JJ, Richmond TA, Mayhew GF, Hill SM, McNally CD, Jones C, Rosenbaum H, Stanislaw S, Burgess DL, Alexander NR, Swanton C; PEACE; TRACERx Renal Consortium. Tracking Cancer Evolution Reveals Constrained Routes to Metastases: TRACERx Renal. Cell. 2018 Apr 19;173(3):581-594.e12. doi: 10.1016/j.cell.2018.03.057. Epub 2018 Apr 12.
PubMed 29656895Turajlic S, Xu H, Litchfield K, Rowan A, Horswell S, Chambers T, O'Brien T, Lopez JI, Watkins TBK, Nicol D, Stares M, Challacombe B, Hazell S, Chandra A, Mitchell TJ, Au L, Eichler-Jonsson C, Jabbar F, Soultati A, Chowdhury S, Rudman S, Lynch J, Fernando A, Stamp G, Nye E, Stewart A, Xing W, Smith JC, Escudero M, Huffman A, Matthews N, Elgar G, Phillimore B, Costa M, Begum S, Ward S, Salm M, Boeing S, Fisher R, Spain L, Navas C, Gronroos E, Hobor S, Sharma S, Aurangzeb I, Lall S, Polson A, Varia M, Horsfield C, Fotiadis N, Pickering L, Schwarz RF, Silva B, Herrero J, Luscombe NM, Jamal-Hanjani M, Rosenthal R, Birkbak NJ, Wilson GA, Pipek O, Ribli D, Krzystanek M, Csabai I, Szallasi Z, Gore M, McGranahan N, Van Loo P, Campbell P, Larkin J, Swanton C; TRACERx Renal Consortium. Deterministic Evolutionary Trajectories Influence Primary Tumor Growth: TRACERx Renal. Cell. 2018 Apr 19;173(3):595-610.e11. doi: 10.1016/j.cell.2018.03.043. Epub 2018 Apr 12.
PubMed 29656894
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRACERx Renal (TRAcking Renal Cell Carcinoma Evolution Through Therapy (Rx)) CAPTURE: COVID-19 Antiviral Response in a Pan-tumour Immune Study
- ClinicalTrials.gov ID
- NCT03226886
- Acronym / sponsor ID
- TRACERxRenal / CCR 3723
- Conditions
- Renal Cell Carcinoma, Cancer, Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Royal Marsden NHS Foundation TrustUniversity, hospital or other
- Collaborators
- Francis Crick Institute
- Study start
- 5 Feb 2012 (actual)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Sep 2023 (estimated)
- First posted
- 24 Jul 2017 (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.
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
Detailed description
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 validate ITH index and WGII as stage and grade independent prognostic markers of progression free survival in patients with ccRCC
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
CAPTURE sub-study:
There is an urgent need to quantify the risk of COVID-19 illness in patients with cancer and to understand what impact anti-cancer treatments have on the immune system's response to the SARS-CoV-2 virus. There is also a need to understand how the pandemic impacts Health Care Workers (HCWs) who may be exposed to the virus in the course of their clinical duties and who are at risk to transmit the virus to vulnerable patients and colleagues in the asymptomatic phase of infection.
The CAPTURE study is a long-term study. We are establishing large observational cohorts with an intentionally broad inclusion of different tumour types and treatment schedules. In CAPTURE, we will enrol both patients infected and uninfected by the virus, and patients with all types of cancer (blood and solid cancers), and of all walks of the clinical journey (in remission, follow-up, having treatment or undergoing surgery). We also will enrol HCWs within the hospital from all sectors of care delivery - from nurses to doctors, administrative staff to catering staff, allied health and support workers.
The study will enrol patients/participants into three groups:
Group A: patients with confirmed or suspected COVID-19 and a history of cancer (n=200) Group B: patients without a history of COVID-19 infection and a history of cancer (n=1000) Group C: Hospital staff with or without a history of COVID-19 (n=200)
Comprehensive, longitudinal clinical annotation, participant questionnaires, meticulous and frequent sampling and long-term follow-up of these groups will allow robust and rapid insights that are urgently needed to guide clinical and workforce management.
This knowledge is required well beyond the current pandemic as cancer and SARSCo-V2 will coincide in the same patients, and especially given the uncertainty regarding the nature and duration of immunity in cancer patients who develop the illness and the effectiveness of vaccines in the cancer population. This study will provide us with detailed information on how to safely manage cancer patients by both minimising the risk of infection but maintaining their cancer treatment.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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)
Key inclusion criteria (0 listed)
Key exclusion criteria (10 listed)
- 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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2020.
- Derived from this study: PubMed 37580840Orton MR, Hann E, Doran SJ, Shepherd STC, Ap Dafydd D, Spencer CE, Lopez JI, Albarran-Artahona V, Comito F, Warren H, Shur J, Messiou C, Larkin J, Turajlic S; TRACERx Renal Consortium; Koh DM. Interpretability of radiomics models is improved when using feature group selection strategies for predicting molecular and clinical targets in clear-cell renal cell carcinoma: insights from the TRACERx Renal study. Cancer Imaging. 2023 Aug 14;23(1):76. doi: 10.1186/s40644-023-00594-3.
- Derived from this study: PubMed 36582225Piening A, Ebert E, Khojandi N, Alspach E, Teague RM. Immune responses to SARS-CoV-2 in vaccinated patients receiving checkpoint blockade immunotherapy for cancer. Front Immunol. 2022 Dec 13;13:1022732. doi: 10.3389/fimmu.2022.1022732. eCollection 2022.
- Derived from this study: PubMed 36240755Fendler A, Shepherd STC, Au L, Wu M, Harvey R, Wilkinson KA, Schmitt AM, Tippu Z, Shum B, Farag S, Rogiers A, Carlyle E, Edmonds K, Del Rosario L, Lingard K, Mangwende M, Holt L, Ahmod H, Korteweg J, Foley T, Barber T, Emslie-Henry A, Caulfield-Lynch N, Byrne F, Deng D, Kjaer S, Song OR, Queval CJ, Kavanagh C, Wall EC, Carr EJ, Caidan S, Gavrielides M, MacRae JI, Kelly G, Peat K, Kelly D, Murra A, Kelly K, O'Flaherty M, Shea RL, Gardner G, Murray D, Popat S, Yousaf N, Jhanji S, Tatham K, Cunningham D, Van As N, Young K, Furness AJS, Pickering L, Beale R, Swanton C, Gandhi S, Gamblin S, Bauer DLV, Kassiotis G, Howell M, Nicholson E, Walker S, Wilkinson RJ, Larkin J, Turajlic S. Functional immune responses against SARS-CoV-2 variants of concern after fourth COVID-19 vaccine dose or infection in patients with blood cancer. Cell Rep Med. 2022 Oct 18;3(10):100781. doi: 10.1016/j.xcrm.2022.100781. Epub 2022 Sep 27.
- Derived from this study: PubMed 35121899Fendler A, Shepherd STC, Au L, Wilkinson KA, Wu M, Byrne F, Cerrone M, Schmitt AM, Joharatnam-Hogan N, Shum B, Tippu Z, Rzeniewicz K, Boos LA, Harvey R, Carlyle E, Edmonds K, Del Rosario L, Sarker S, Lingard K, Mangwende M, Holt L, Ahmod H, Korteweg J, Foley T, Bazin J, Gordon W, Barber T, Emslie-Henry A, Xie W, Gerard CL, Deng D, Wall EC, Agua-Doce A, Namjou S, Caidan S, Gavrielides M, MacRae JI, Kelly G, Peat K, Kelly D, Murra A, Kelly K, O'Flaherty M, Dowdie L, Ash N, Gronthoud F, Shea RL, Gardner G, Murray D, Kinnaird F, Cui W, Pascual J, Rodney S, Mencel J, Curtis O, Stephenson C, Robinson A, Oza B, Farag S, Leslie I, Rogiers A, Iyengar S, Ethell M, Messiou C, Cunningham D, Chau I, Starling N, Turner N, Welsh L, van As N, Jones RL, Droney J, Banerjee S, Tatham KC, O'Brien M, Harrington K, Bhide S, Okines A, Reid A, Young K, Furness AJS, Pickering L, Swanton C; Crick COVID-19 Consortium; Gandhi S, Gamblin S, Bauer DLV, Kassiotis G, Kumar S, Yousaf N, Jhanji S, Nicholson E, Howell M, Walker S, Wilkinson RJ, Larkin J, Turajlic S; CAPTURE Consortium. Adaptive immunity and neutralizing antibodies against SARS-CoV-2 variants of concern following vaccination in patients with cancer: the CAPTURE study. Nat Cancer. 2021 Dec;2(12):1305-1320. doi: 10.1038/s43018-021-00274-w. Epub 2021 Oct 27.
- Derived from this study: PubMed 34950880Fendler A, Shepherd STC, Au L, Wilkinson KA, Wu M, Byrne F, Cerrone M, Schmitt AM, Joharatnam-Hogan N, Shum B, Tippu Z, Rzeniewicz K, Boos LA, Harvey R, Carlyle E, Edmonds K, Del Rosario L, Sarker S, Lingard K, Mangwende M, Holt L, Ahmod H, Korteweg J, Foley T, Bazin J, Gordon W, Barber T, Emslie-Henry A, Xie W, Gerard CL, Deng D, Wall EC, Agua-Doce A, Namjou S, Caidan S, Gavrielides M, MacRae JI, Kelly G, Peat K, Kelly D, Murra A, Kelly K, O'Flaherty M, Dowdie L, Ash N, Gronthoud F, Shea RL, Gardner G, Murray D, Kinnaird F, Cui W, Pascual J, Rodney S, Mencel J, Curtis O, Stephenson C, Robinson A, Oza B, Farag S, Leslie I, Rogiers A, Iyengar S, Ethell M, Messiou C, Cunningham D, Chau I, Starling N, Turner N, Welsh L, van As N, Jones RL, Droney J, Banerjee S, Tatham KC, O'Brien M, Harrington K, Bhide S, Okines A, Reid A, Young K, Furness AJS, Pickering L, Swanton C; Crick COVID19 consortium; Gandhi S, Gamblin S, Bauer DL, Kassiotis G, Kumar S, Yousaf N, Jhanji S, Nicholson E, Howell M, Walker S, Wilkinson RJ, Larkin J, Turajlic S. Adaptive immunity and neutralizing antibodies against SARS-CoV-2 variants of concern following vaccination in patients with cancer: The CAPTURE study. Nat Cancer. 2021 Dec;2:1321-1337. doi: 10.1038/s43018-021-00274-w. Epub 2021 Oct 27.
- Derived from this study: PubMed 29656895Turajlic S, Xu H, Litchfield K, Rowan A, Chambers T, Lopez JI, Nicol D, O'Brien T, Larkin J, Horswell S, Stares M, Au L, Jamal-Hanjani M, Challacombe B, Chandra A, Hazell S, Eichler-Jonsson C, Soultati A, Chowdhury S, Rudman S, Lynch J, Fernando A, Stamp G, Nye E, Jabbar F, Spain L, Lall S, Guarch R, Falzon M, Proctor I, Pickering L, Gore M, Watkins TBK, Ward S, Stewart A, DiNatale R, Becerra MF, Reznik E, Hsieh JJ, Richmond TA, Mayhew GF, Hill SM, McNally CD, Jones C, Rosenbaum H, Stanislaw S, Burgess DL, Alexander NR, Swanton C; PEACE; TRACERx Renal Consortium. Tracking Cancer Evolution Reveals Constrained Routes to Metastases: TRACERx Renal. Cell. 2018 Apr 19;173(3):581-594.e12. doi: 10.1016/j.cell.2018.03.057. Epub 2018 Apr 12.
- Derived from this study: PubMed 29656894Turajlic S, Xu H, Litchfield K, Rowan A, Horswell S, Chambers T, O'Brien T, Lopez JI, Watkins TBK, Nicol D, Stares M, Challacombe B, Hazell S, Chandra A, Mitchell TJ, Au L, Eichler-Jonsson C, Jabbar F, Soultati A, Chowdhury S, Rudman S, Lynch J, Fernando A, Stamp G, Nye E, Stewart A, Xing W, Smith JC, Escudero M, Huffman A, Matthews N, Elgar G, Phillimore B, Costa M, Begum S, Ward S, Salm M, Boeing S, Fisher R, Spain L, Navas C, Gronroos E, Hobor S, Sharma S, Aurangzeb I, Lall S, Polson A, Varia M, Horsfield C, Fotiadis N, Pickering L, Schwarz RF, Silva B, Herrero J, Luscombe NM, Jamal-Hanjani M, Rosenthal R, Birkbak NJ, Wilson GA, Pipek O, Ribli D, Krzystanek M, Csabai I, Szallasi Z, Gore M, McGranahan N, Van Loo P, Campbell P, Larkin J, Swanton C; TRACERx Renal Consortium. Deterministic Evolutionary Trajectories Influence Primary Tumor Growth: TRACERx Renal. Cell. 2018 Apr 19;173(3):595-610.e11. doi: 10.1016/j.cell.2018.03.043. Epub 2018 Apr 12.
- TRACERx Consortium WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. 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.
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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.
Samra Turajlic principal investigator
Royal Marsden NHS Foundation Trust
4 sites 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 and Cancer, run by Royal Marsden NHS Foundation Trust at 4 sites in United Kingdom.
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 0 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 25 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samra Turajlic (0207 811 8576, Samra.Turajlic@crick.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). 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?
On the ClinicalTrials.gov record for NCT03226886, which also lists 7 linked publications.
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 25 Aug 2020.