KIDSTAGE- Staging of Kidney Cancer Using Dual Time PET/CT and Other Biomarkers

NCT04295174 | Completed DMC

• 1 other identifier: S-20160005
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

Kidney cancer is a highly malignant disease with 950 new cases every year in Denmark. 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. Metastasis is a predictor of bad prognosis, because the presence of metastases excludes the possibility of curative treatment (surgery). Systemic (medical) treatment is used for metastatic disease. It is of increasing importance to monitor how patients are responding to the treatment and switch to a different product if the tumor is not responding. Improved methods for detection of metastatic lesions would be of great advantaged for the clinicians in order to select the optimal treatment strategy for the patients. In the present study we aim to identify tumor markers in the blood and more specific we want to investigate whether circulating tumor-DNA can be used as a biomarker for monitoring the development of the disease during and after treatment. We want a better understanding of the tumor's heterogeneity and development. Furthermore we want to evaluate the diagnostic value of dual time FDG- PET/CT for the detection of bone and lymph node metastases in patients with kidney cancer

Conditions

Carcinoma, Renal Cell

Keywords

circulating tumor DNA

Outcome Measures

Primary Outcomes (2)

• circulating tumor DNA in patients with renal cell carcinoma

  investigating if circulating tumor DNA can be used to monitor tumor burden and disease progression in patients with renal cell carcinoma

  3 years

• Dual time point FDG PET/CT in patients with renal cell carcinoma

  investigating if Dual time point FDG PET/CT can be used in staging of renal cell carcinoma

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with renal cell carcinoma in The Urological Department and in The Oncological Department of OUH are eligible for enrolment in the study

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense University Hospital

Odense C, Odense, 5000, Denmark

Location

Biospecimen

Retention: SAMPLES WITH DNA

Collection of tumorsamples and blodsamles before and after nephrectomy in patients with renal cell carcinoma

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Lars Lund, MD, DMSci

  Professor, Consultant Urology, Department of Urology, Odense University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor

Study Record Dates

• First Submitted: March 3, 2020
• First Posted: March 4, 2020
• Study Start: January 1, 2018
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: March 4, 2020

Record last verified: 2020-03

Locations

DK (1)