KIDNEY-PAGER: Analysis of Circulating Tumor DNA as a Biomarker in Renal Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- University of Aarhus
- Enrollment
- 500
- Locations
- 1
- Primary Endpoint
- ctDNA can identify high risk patients
Study Overview
Brief Summary
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.
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
- 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported