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Status unknownNCT04060537ARTIST_RCCUpdated Aug 19, 2019

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

An observational study in Carcinoma, Renal Cell, sponsored by CCTU- Cancer Theme. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-08-19.

Sponsored by CCTU- Cancer Theme · Observational

The sponsor has not verified this record recently (last verified Aug 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
12
Ages
18 Years and older
Sex
All
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Study 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.

Read the detailed description

This research study aims to investigate changes inside kidney cancers, and in normal kidney surrounding the tumour, when patients are treated with systemic therapy. Systemic treatment is widely used as routine treatment for patients who have kidney cancer that has spread to other organs. It is also used sometimes before surgery to try to shrink kidney cancers to make surgery easier and less risky. Recent research has shown that kidney cancers consist of many different cells in addition to the cancer cells (including immune, structural and blood vessel cells). However, doctors know very little about what changes systemic therapy causes to cells other than cancer cells.

Researchers now think that these other cells may influence how the tumour cells behave during cancer treatment and how well the cancer responds to treatment.

The NeoSUN clinical trial was run at Cambridge University Hospitals between 2006 and 2015.18 patients were treated with a TKI called sunitinib for 12 days before they had their kidney surgically removed. MRI and CT scans were performed before and after the treatment. Samples of tumour and normal kidney were also taken before and after treatment. All patients consented to use of their tissue and data for future research projects. The investigators would like to analyse the effects that sunitinib had on the tumour and other cells using techniques called immunohistochemistry, immunofluorescence, and CyTOF. These mark the different cells so they can easily be identified and the effects on each one analysed. The investigators would also like to re-analyse the scans performed and use artificial intelligence (AI) to see try to detect new trends. The information may help to guide which drugs might be best used in future to treat kidney cancer more effectively whilst keeping side effects low.

02

Conditions studied

  • Carcinoma, Renal Cell

Keywords

  • Cancer
  • Renal
  • Tyrosine Kinase Inhibitors
  • Systemic Treatments
  • Biomarkers
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In context

Carcinoma, Renal Cell

1,964 studies on the registry are indexed under Carcinoma, Renal Cell; 377 are open to participants now.

This study's planned enrollment of 12 is below the median of 146 across 360 observational studies indexed under Carcinoma, Renal Cell.

Browse Carcinoma, Renal Cell studies →

Lead sponsor

CCTU- Cancer Theme is the lead sponsor of 19 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  1. Aged 18 years or older
  2. Diagnosis of renal cell cancer (any stage).
  3. Patient received systemic treatment for their renal cancer at Cambridge University Hospitals NHS Foundation Trust.
  4. 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.
  5. Participants must also meet at least one of the following criteria to be eligible:

    1. 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).
    2. 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.

Exclusion criteria

Exclusion Criteria:

None

05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
12 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • OtherLaboratory analysis of samples

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

  • OtherApplication of machine learning

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

  2. 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.

    Time frame: 2 years

  3. 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.

    Time frame: 2 years

  4. 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.

    Time frame: 2 years

  5. 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.

    Time frame: 2 years

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04060537
Lead sponsor
CCTU- Cancer Theme
Responsible party
CCTU- Cancer Theme (Dr. Sarah J. Welsh, Cambridge University Hospitals NHS Foundation Trust) — Sponsor-investigator
First posted
Aug 19, 2019
Start date
Jan 2020 (estimated)
Primary completion
Jan 2022 (estimated)
Completion
Jan 2022 (estimated)
Last update
Aug 19, 2019

Study contacts

Richard Skells
Contact
richard.skells@addenbrookes.nhs.uk
01223348454
Amanda Walker
Contact
amanda.walker@addenbrookes.nhs.uk
01223256364
Sarah Welsh
principal investigator · Cambridge University Hospitals

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2019. You cannot join it, but the record below documents what was studied.

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