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

See Contacts and Locations

Sponsor:

Collaborator:

The Francis Crick Institute

Information provided by (Responsible Party):

Royal Marsden NHS Foundation Trust

Study Description

Brief 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

Condition or disease
Renal Cell Carcinoma Cancer Healthy Volunteers

Show detailed description

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

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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

Resource links provided by the National Library of Medicine

Genetic and Rare Diseases Information Center resources: Renal Cell Carcinoma Clear Cell Renal Cell Carcinoma

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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

Group/Cohort

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

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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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

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)

Criteria

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

Contacts and Locations

Information from the National Library of Medicine

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

Contacts

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Contact: Samra Turajlic	0207 811 8576	Samra.Turajlic@crick.ac.uk
Contact: Ellie Carlyle	0207 808 2752	eleanor.carlyle@rmh.nhs.uk

Locations

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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

Sponsors and Collaborators

Royal Marsden NHS Foundation Trust

The Francis Crick Institute

Investigators

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Principal Investigator:	Samra Turajlic	Royal Marsden NHS Foundation Trust

More Information

Additional Information:

TRACERx Consortium Website This link exits the ClinicalTrials.gov site

CAPTURE Website This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Turajlic 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.

Turajlic 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, Grönroos 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.

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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.

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Additional relevant MeSH terms:

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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

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