Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

TRACERx Renal (TRAcking Renal Cell Carcinoma Evolution Through Therapy (Rx)) (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 : September 23, 2019
Sponsor:
Information provided by (Responsible Party):
Royal Marsden NHS Foundation Trust

Brief Summary:
This is a translational study, which, aims to develop prognostic and predictive biomarkers for patients with renal cell carcinoma (RCC).

Condition or disease
Renal Cell Carcinoma

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 calculate the proportion of patients who are in possession of a mutation in a gene of interest

The Investigators expect to collect 360 specimens by 2018 at an ongoing rate of approximately 60 per year.

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

Layout table for study information
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))
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.



Primary Outcome Measures :
  1. 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.


Biospecimen Retention:   Samples With DNA
The Investigators will be collecting Blood, Urine, Core Biopsies and Surgical Samples


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

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

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

Locations
Layout table for location information
United Kingdom
Edinburgh Western General Hospital Recruiting
Edinburgh, Scotland, United Kingdom, EH4 2XU
Contact: Steve Leung       steve.leung@nhs.net   
Guy's & St Thomas Hospital Recruiting
London, UK, United Kingdom, SE1 9RT
Contact: Dr Simon Chowdhury    02071887188    Simon.Chowdhury@gstt.nhs.uk   
Contact: Sharanpreet Lall    020 7188 2007    sharanpreet.lall@kcl.ac.uk   
Royal Free Hospital Recruiting
London, United Kingdom, NW3 2QC
Contact: Dr Michael Aitchinson       michael.aitchison@nhs.net   
Sponsors and Collaborators
Royal Marsden NHS Foundation Trust
Investigators
Layout table for investigator information
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.

Layout table for additonal information
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: September 23, 2019
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.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
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