Renal Cancer Detection With Liquid Biopsy

Recruiting

• Conditions: Renal Cancer; Oncocytoma
• Interventions: Diagnostic Test: GaGnostic

• Registration Number: NCT05060783
• Lead Sponsor: Zealand University Hospital

Brief Summary

Glycosaminoglycans (GAGs) were significantly altered in localized as well advanced RCC compared to healthy samples. In addition, GAG scores correlated with progression-free survival and overall survival (OS) in a prospective cohort of patients with metastatic ccRCC and localized RCC. However, it is still unknown whether alterations in plasma and urine GAGs are exquisitely specific to RCC or are shared by other benign lesions in the kidney, such as angiomyolipomas, oncocytomas, or PEComa.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Study First Submitted: 2021-09-16
• Study First Submitted QC: 2021-09-28
• Study First Posted: 2021-09-29
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-27
• Last Update Posted: 2024-01-30
• Primary Completion: 2025-07-01
• Study Completion: 2027-07-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patients who underwent CT-scan with suspicion of renal tumor and the scans show no sign of renal cancer.
2. For patient with ccRCC or oncocytoma, they should have a histological verified tumor (Biopsy or surgical specimen)
3. Sign up information consent
4. Can perform protocol procedure

Exclusion Criteria

1. Non-clear cell Renal cell carcinoma
2. RCC with pure sarcomatoid differentiation, also called sarcoma of the kidney
3. Use of heparin for concurrent disease in need of blood dilution (e.g. ongoing deep vein thrombosis or lung emboli). Note: use of of heparin for thrombus prophylaxis in conjunction with primary surgery or postoperatively ≤4 weeks will be allowed.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy persons	GaGnostic	Patients with CT scan shows no renal cancer
Oncocytoma	GaGnostic	Patients with oncocytoma
Renal Call Carcinoma	GaGnostic	Patrients with renal cancer

Primary Outcome Measures

Name	Time	Method
To identify the optimal GAG score	2 years	To identify the optimal GAG score in healthy individuel

Trial Locations

Locations (1)

Zealand University Hospital; 🇩🇰 Roskilde, Denmark