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Trial record 55 of 2235 for:    Recruiting, Not yet recruiting, Available Studies | Renal

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

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ClinicalTrials.gov Identifier: NCT04060537
Recruitment Status : Not yet recruiting
First Posted : August 19, 2019
Last Update Posted : August 19, 2019
Sponsor:
Information provided by (Responsible Party):
CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust

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.


Condition or disease Intervention/treatment
Carcinoma, Renal Cell Other: Laboratory analysis of samples Other: Application of machine learning

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.


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Study Type : Observational
Estimated Enrollment : 12 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Retrospective Translational Study to Identify Novel Biomarkers of Response to Systemic Treatments in Renal Cell Cancer
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : January 2022
Estimated Study Completion Date : January 2022

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Research
Patients with Renal Cell Carcinoma who have had previous systemic treatment, with adequate tissue samples and radiological data
Other: Laboratory analysis of samples
RNA sequencing, immunohistochemistry, immunofluorescence, and cytometry of tumour tissues

Other: Application 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.




Primary Outcome Measures :
  1. Biological identification of biomarkers of response to systemic treatment in Renal Cell Cancer. [ Time Frame: 2 years ]
    Using data from RNA sequencing of tumour tissues, the outcome is to identify novel biomarkers of response.

  2. Radiological identification of biomarkers of response to systemic treatment in Renal Cell Cancer. [ Time Frame: 2 years ]
    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.

  3. Biological identification of biomarkers of response to systemic treatment in Renal Cell Cancer. [ Time Frame: 2 years ]
    Using data from immunohistochemistry, the outcome is to identify novel biomarkers of response.

  4. Biological identification of biomarkers of response to systemic treatment in Renal Cell Cancer. [ Time Frame: 2 years ]
    Using data from immunofluorescence, the outcome is to identify novel biomarkers of response.

  5. Biological identification of biomarkers of response to systemic treatment in Renal Cell Cancer. [ Time Frame: 2 years ]
    Using data from CyTOF (mass cytometry), the outcome is to identify novel biomarkers of response.


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


Information from the National Library of Medicine

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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
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.
Criteria

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:

None


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): NCT04060537


Contacts
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Contact: Richard Skells 01223348454 richard.skells@addenbrookes.nhs.uk
Contact: Amanda Walker 01223256364 amanda.walker@addenbrookes.nhs.uk

Sponsors and Collaborators
CCTU- Cancer Theme
Investigators
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Principal Investigator: Sarah Welsh Cambridge University Hospitals

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Responsible Party: CCTU- Cancer Theme, Dr. Sarah J. Welsh, Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT04060537     History of Changes
Other Study ID Numbers: ARTIST RCC
First Posted: August 19, 2019    Key Record Dates
Last Update Posted: August 19, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by CCTU- Cancer Theme, Cambridge University Hospitals NHS Foundation Trust:
Cancer
Renal
Tyrosine Kinase Inhibitors
Systemic Treatments
Biomarkers
Additional relevant MeSH terms:
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Carcinoma, Renal Cell
Kidney Neoplasms
Kidney Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urologic Diseases