Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

TRACERx Renal CAPTURE Sub-study (TRACERxRenal)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03226886
Recruitment Status : Recruiting
First Posted : July 24, 2017
Last Update Posted : August 25, 2020
Sponsor:
Collaborator:
The Francis Crick Institute
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Tracking Information
First Submitted Date July 6, 2017
First Posted Date July 24, 2017
Last Update Posted Date August 25, 2020
Actual Study Start Date February 5, 2012
Estimated Primary Completion Date September 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 21, 2020)
  • 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
Original Primary Outcome Measures
 (submitted: July 20, 2017)
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.
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:

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

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)

Condition
  • Renal Cell Carcinoma
  • Cancer
  • Healthy Volunteers
Intervention Not Provided
Study Groups/Cohorts 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

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 20, 2017)
360
Original Estimated Enrollment Same as current
Estimated Study Completion Date September 1, 2023
Estimated Primary Completion Date September 1, 2023   (Final data collection date for primary outcome measure)
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

Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Samra Turajlic 0207 811 8576 Samra.Turajlic@crick.ac.uk
Contact: Ellie Carlyle 0207 808 2752 eleanor.carlyle@rmh.nhs.uk
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT03226886
Other Study ID Numbers CCR 3723
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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.
Responsible Party Royal Marsden NHS Foundation Trust
Study Sponsor Royal Marsden NHS Foundation Trust
Collaborators The Francis Crick Institute
Investigators
Principal Investigator: Samra Turajlic Royal Marsden NHS Foundation Trust
PRS Account Royal Marsden NHS Foundation Trust
Verification Date September 2019