Short summary

Kidney cancer (KC) is a highly malignant disease with 900 new cases and 200 deaths caused by the disease each year in Denmark. Diagnosis and treatment of patients with KC presents many challenges. Early stages of KC are often asymptomatic and the disease is thus often at advanced- or even metastatic stage when discovered. If the study provides us positive results it will give us entirely new knowledge in the field of the KC disease. This knowledge can lead to better treatment for the individual patient due to the fact that the patients are more likely to receive the right treatment up front as a result of the better staging at diagnosis. With positive results it could be possible for us to develop a screening tool for KC patients in the future.

Rationale

Background

Kidney cancer (KC) is a highly malignant disease with 900 new cases each year in DK and the incidence is increasing. Diagnosis and treatment of kidney cancer patients presents many challenges because that early stages of the disease are often asymptomatic and the disease is thus often at advanced stage or even metastatic when discovered. Metastases including lymph node metastasis are a predictor of severe prognosis. Surgical removal of metastatic lymph nodes has been shown to improve response to systemic treatment and prolonged survival, but the current methods for detection of especially lymph node metastasis are however insufficient. Improved methods for detection of metastatic lesions at the time of diagnosis would be of great advantage for the clinicians in order to select the best treatment strategy for the patients. Surgery is the only curative treatment available. Systemic treatment is used in case of metastatic disease. Metastatic KC is generally non-responsive to chemotherapeutics and radiation therapy but a range of other systemic treatment options has been developed over the last decade. This means that it is of increasing importance to monitor how patients are responding to the selected treatment and switch to a different product if the tumor is not responding

PET/CT is a well-established method of diagnosing and staging several types of cancer and recently PET/CT has shown promising results in staging of KC. Floudoxyglycose (FDG) is a radioactive labelled tracer and it is the most common PET/CT tracer. FDG uptake vary over time in malignant and benign processes and Dual time point (DTP) FGD PET/CT allows for distinction between them and might result in better staging of KC-patients.

Tumor burden is reflected in circulating tumorDNA (ctDNA), which can be measured in blood-and urine samples. CtDNA is expected to provide information about changes in tumor load before/during treatment

Aims
1. To evaluate the diagnostic value of PET/CT for the detection of bone and lymph node metastases in patients with KC
2. To investigate whether circulating tumor-DNA can be used as a marker for disease progression and treatment of patients with KC.

We assume that the results of the study using PET/CT will guide us further in the development of a better diagnostic tool for staging of KC that is both accurate and noninvasive. Identification of circulating biomarkers would set the basis for a completely non-invasive diagnostic program. It would thus include a "full liquid biopsy", eliminating the risks related to any invasive approach and the uncertainty related to the limitations of biopsy sampling.

Description of the cohort

Population:
All patients diagnosed with kidney cancer (KC) in The Urological Department and in The Oncological Department of OUH are eligible for enrolment in the study.
Inclusion criteria:

• KC patients at Urological-and Oncological departments of OUH 
• Written consent
• Able to speak and understand Danish

Exclusion criteria: 

• Patients below 18 years of age
• Patients with mental impairment
• Withdrawal of consent
• Other malignancy

Data and biological material

Baseline blood and urine samples will be collected before initiation of treatment.  Sample collection will be repeated at all visits in Urological Department and Oncological Department.

Tissue sample from the tumor will be collected during the operation or if an ultrasound guided biopsy of the tumor and/or the metastases is performed 

Collaborating researchers and departments

Department of Urology L, Odense University Hospital

• Professor Lars Lund, MD, DMSci (main supervisor)

Department of Oncology R, Odense University Hospital

• Consultant Niels Viggo Jensen, MD (co supervisor)

Department of Nuclear Medicine, Odense University Hospital

• Consultant Jane Simonsen, MD, PhD (co supervisor)

Department of Clinical Genetics, Odense University Hospital

• Professor Torben Kruse, MD, DMSci (co supervisor)

Department of Pathology, Odense University Hospital

• Professor Niels Marcussen, MD, DMSci

Department of Urology, Vanderbilt University, TN, USA

• Professor Peter Clark, MD