Identification of Novel Biomarkers of Response to Systemic Treatments in Renal Cell Cancer

NCT04060537 | Unknown

• 1 other identifier: ARTIST RCC
• Study Type: observational
• Target: 12
• Locations: 0 countries
• Sites: N/A

Brief Summary

This research study aims to investigate changes inside kidney cancers (also known as Renal Cell Carcinoma or RCC), and in normal kidney surrounding the tumour, when patients are treated with systemic therapy. Samples, radiological images and data from a previous trial (NeoSUN) will be analysed and/or reanalysed, in accordance with the consent of NeoSUN participants.

Conditions

Carcinoma, Renal Cell

Keywords

Cancer; Renal; Tyrosine Kinase Inhibitors; Systemic Treatments; Biomarkers

Outcome Measures

Primary Outcomes (5)

• Biological identification of biomarkers of response to systemic treatment in Renal Cell Cancer.

  Using data from RNA sequencing of tumour tissues, the outcome is to identify novel biomarkers of response.

  2 years

• Radiological identification of biomarkers of response to systemic treatment in Renal Cell Cancer.

  Using data from MRI imaging by analysis of the tumour microenvironment and machine learning interrogation of output data, the outcome is to identify novel biomarkers of response.

  2 years

• Biological identification of biomarkers of response to systemic treatment in Renal Cell Cancer.

  Using data from immunohistochemistry, the outcome is to identify novel biomarkers of response.

  2 years

• Biological identification of biomarkers of response to systemic treatment in Renal Cell Cancer.

  Using data from immunofluorescence, the outcome is to identify novel biomarkers of response.

  2 years

• Biological identification of biomarkers of response to systemic treatment in Renal Cell Cancer.

  Using data from CyTOF (mass cytometry), the outcome is to identify novel biomarkers of response.

  2 years

Study Arms (1)

Research

Patients with Renal Cell Carcinoma who have had previous systemic treatment, with adequate tissue samples and radiological data

Other: Laboratory analysis of samples; Other: Application of machine learning

Interventions

Laboratory analysis of samples OTHER

RNA sequencing, immunohistochemistry, immunofluorescence, and cytometry of tumour tissues

Research

Application of machine learning OTHER

Using machine learning to interrogate data generated from analysis of Renal Cell Cancer tumours using RNA sequencing, immunohistochemistry, immunofluorescence, cytometry, and MRI imaging of tumours.

Research

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with renal cell cancer who have given prior consent under NeoSUN for their samples and data to be used, and who have adequate samples and data available.

You may qualify if:

• Aged 18 years or older
• Diagnosis of renal cell cancer (any stage).
• Patient received systemic treatment for their renal cancer at Cambridge University Hospitals NHS Foundation Trust.
• Patients must have consent in place, for the use of tissue and imaging to be used for the purposes of clinical research;
• Use of tissue not required for their diagnosis or treatment to be stored and used for the purposes of clinical research, which may include genetic research.
• Use of relevant sections of their medical records, or by relevant regulatory authorities, where my tissue is being used for research, giving permission for those individuals to have access to their medical records.
• Participants must also meet at least one of the following criteria to be eligible:
• For tissue analysis: Patient must have tumour tissue and/or normal adjacent kidney stored (either as formalinfixed paraffin-embedded tissue, or as 'fresh frozen' tissue).
• For imaging analysis: Patient must have had at least 1 scan (either CT or MRI) within 28 days of starting treatment with systemic treatment for their cancer.

You may not qualify if:

• None

Sponsors & Collaborators

• CCTU- Cancer Theme: lead

Biospecimen

Retention: SAMPLES WITH DNA

Renal Cell Carcinoma tumour specimen (tissue block or slides), kidney tissue specimen (tissue block or slides), previously obtained with consent under NeoSUN study

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Sarah Welsh

  Cambridge University Hospitals

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Richard Skells

CONTACT

01223348454; richard.skells@addenbrookes.nhs.uk

Amanda Walker

CONTACT

01223256364; amanda.walker@addenbrookes.nhs.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr. Sarah J. Welsh

Study Record Dates

• First Submitted: August 13, 2019
• First Posted: August 19, 2019
• Study Start: January 1, 2020
• Primary Completion: January 1, 2022
• Study Completion: January 1, 2022
• Last Updated: August 19, 2019

Record last verified: 2019-08