KIDNEY-PAGER: Analysis of Circulating Tumor DNA as a Biomarker in Renal Cancer - an Observational Trial (KIDNEY-PAGER)

November 21, 2023 updated by: University of Aarhus

KIDNEY-PAGER: Analysis of Circulating Tumor DNA as a Biomarker in Renal Cancer

The overall aim of this observational study is to confirm that circulating tumor DNA (ctDNA) detected in plasma and or urine after intended curative treatment for renal cell carcinoma (RCC) can be applied in clinical practice as a marker of subclinical residual disease and risk of recurrence.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

OBJECTIVES

The overall objective of the study is to confirm that circulating tumor DNA (ctDNA) detected in plasma and or urine after intended curative treatment for RCC can be applied in clinical practice as a marker of subclinical residual disease and risk of recurrence.

1.1 Primary objectives

  1. To confirm that patients with high risk of recurrence can be identified with ctDNA profiling performed immediately after nephrectomy.

    Specifically, we aim to determine in patients with localized RCC (stages I-III) if the three-year disease-free survival is associated with detection of ctDNA in plasma immediately after surgery.

    1.2 Secondary objectives

  2. To show that detection of ctDNA pre- and post-operatively can be applied as a risk stratification tool.
  3. To validate the potential of a ctDNA-guided follow-up program as compared to the current CT-scan follow-up program. More specifically, to investigate the correlation between ctDNA and CT-scanning findings. The potential is that ctDNA analysis predicts the CT-scan result and can be used to guide when to perform a CT-scan. Potentially, it also adds evidence for the results of CT-scans performed subsequently to an uncertain CT-scan result.
  4. To investigate if time to Molecular recurrence using serial ctDNA analysis of longitudinally collected blood samples is shorter than time to Clinical recurrence using standard-of-care radiological imaging surveillance.
  5. To find and validate predictive blood- and or tissue-based biomarkers for immunotherapy and or targeted therapies with the aim to identify patients that are more likely to respond to the given therapy administered.
  6. To confirm that changes in ctDNA levels reflect the therapeutic effect of the given therapy, such as immunotherapy and or targeted therapies.
  7. To delineate markers of tumor aggressiveness and compare to ctDNA measurements

2 INVESTIGATIONAL PLAN

2.1 Overall study design

This study is based on a comprehensive series of blood sampling prospectively and ctDNA analysis performed in RCC patients before and after surgery, during and after treatment, and during surveillance. Patients are followed 5 years from date of surgery.

  • Urine, blood sampling and ctDNA analysis pre-operative and immediately after surgery (a postoperative blood sample is drawn on day 14)
  • Sampling of tissue from the biopsy and resected specimen as well as adjacent normal.
  • Longitudinal blood and urine sampling over a 5-year surveillance period - a blood and urine sample will be drawn simultaneously with the standard-of-care CT-scan-based surveillance program, and from metastatic tissue if a relapse occurs.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus N, Denmark
        • Urology Department Aarhus University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients treated with curative intent for kidney cancer at Aarhus University Hospital, Denmark.

Description

Inclusion Criteria:

  • Patients diagnosed with a locoregional cancer in the kidney, and with a tumour available for surgical excision, and sufficient performance status for surgery.
  • Patients with M1 disease, but no evidence of disease after surgery and local treatment of the metastases.
  • Core needle biopsy-proven renal cell carcinoma - all histologic subtypes acceptable, clinical tumour stage I-IV
  • Patients 18 years or older
  • Patients able to understand and sign written informed consent
  • Scheduled for curative intent resectional surgery (partial or radical nephrectomy)

Exclusion Criteria:

  • Patients with local disease who are not being offered a nephrectomy.
  • Patients who are unlikely to comply with the protocol (e.g. uncooperative attitude), inability to return for subsequent visits and/or otherwise considered by the Investigator to be unlikely to complete the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ctDNA can identify high risk patients
Time Frame: baseline, 1 year, 2 year and 3 year
ctDNA will be determined and levels will be measured, and correlated to relapse status, progression free survival, treatment response and overall survival
baseline, 1 year, 2 year and 3 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

June 1, 2033

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

November 21, 2023

First Posted (Estimated)

November 22, 2023

Study Record Updates

Last Update Posted (Estimated)

November 22, 2023

Last Update Submitted That Met QC Criteria

November 21, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-16-02-476-22

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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