Clinical trial NCT03226886: TRACERx Renal CAPTURE Sub-study
Official title: TRACERx Renal (TRAcking Renal Cell Carcinoma Evolution Through Therapy (Rx)) CAPTURE: COVID-19 Antiviral Response in a Pan-tumour Immune Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Renal Cell Carcinoma
Cancer
Healthy Volunteers
Lead sponsor: Royal Marsden NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: Francis Crick Institute
First posted: 2017-07-24
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
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)

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

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.

Eligibility 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

Primary outcomes:
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
timeFrame: From trial activation until trial closure approximately 1st September 2023
measure: CAPTURE Sub-study: Describe the population characteristics between SARS-CoV-2 positive and negative cancer patients
timeFrame: From sub-study activation until trial closure approximately 2027
Secondary outcomes:
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: Edinburgh Western General Hospital
state: Scotland
city: London
country: United Kingdom
facility: Guy's & St Thomas Hospital
state: UK
city: London
country: United Kingdom
facility: Barts Health NHS Trust
city: London
country: United Kingdom
facility: Royal Free Hospital
Study officials:
affiliation: Royal Marsden NHS Foundation Trust
name: Samra Turajlic
role: PRINCIPAL_INVESTIGATOR
References:
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