Renal Cancer Detection With Liquid Biopsy

Renal Cancer Clinical Trial

— GaGnostic  

Official title:

Renal Cancer Detection With Liquid Biopsy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05060783
• Other study ID #: SJ-894
• Status: Recruiting
• Start date: July 1, 2021
• Est. completion date: July 1, 2027

Study information

• Verified date: January 2024
• Source: Zealand University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2025
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Renal Cell
• Kidney Neoplasms
• Renal Cancer

Intervention

Diagnostic Test:
• GaGnostic
Plasma
• GaGnostic
Serum
• GaGnostic
Urine

Locations

Country	Name	City	State
Denmark	Zealand University Hospital	Roskilde

Sponsors (3)

Lead Sponsor	Collaborator
Zealand University Hospital	Elypta, Lund University

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify the optimal GAG score	To identify the optimal GAG score in RCC patients	2 years
Primary	To identify the optimal GAG score	To identify the optimal GAG score in oncocytoma	2 years
Primary	To identify the optimal GAG score	To identify the optimal GAG score in healthy individuel	2 years