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

NCT06145139 | Enrolling By Invitation

• 1 other identifier: 1-16-02-476-22
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cancer

Keywords

circulating tumor dna

Outcome Measures

Primary Outcomes (1)

• ctDNA can identify high risk patients

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Urology Department Aarhus University Hospital

Aarhus N, Denmark

Location

MeSH Terms

Conditions

Kidney Neoplasms

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: November 22, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2033
• Last Updated: November 22, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)