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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
Sponsor:
Collaborator:
The Francis Crick Institute
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

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

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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


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




Primary Outcome Measures :
  1. 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.

  2. 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



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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


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