Renal Cancer Detection With Liquid Biopsy

NCT05060783 | Recruiting

• 1 other identifier: SJ-894
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Cancer; Oncocytoma

Outcome Measures

Primary Outcomes (3)

• To identify the optimal GAG score

  To identify the optimal GAG score in RCC patients

  2 years

• To identify the optimal GAG score

  To identify the optimal GAG score in oncocytoma

  2 years

• To identify the optimal GAG score

  To identify the optimal GAG score in healthy individuel

  2 years

Study Arms (3)

Renal Call Carcinoma

Patrients with renal cancer

Diagnostic Test: GaGnostic

Oncocytoma

Patients with oncocytoma

Diagnostic Test: GaGnostic

Healthy persons

Patients with CT scan shows no renal cancer

Diagnostic Test: GaGnostic

Interventions

GaGnostic DIAGNOSTIC_TEST

Plasma

Also known as: Glycosaminoglycan

Healthy persons; Oncocytoma; Renal Call Carcinoma

Eligibility Criteria

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

Study Population

All patients referred to our department by family doctors or the primary sector with a suspicion of renal tumor by CT-scanning will be asked to participate in the study. Patients with suspected small renal tumor will be offered renal tumor biopsies as standard procedure.

You may qualify if:

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

You may not qualify if:

• Non-clear cell Renal cell carcinoma
• RCC with pure sarcomatoid differentiation, also called sarcoma of the kidney
• 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.

Sponsors & Collaborators

• Zealand University Hospital: lead
• Lund University: collaborator
• Elypta: collaborator

Study Sites (1)

Zealand University Hospital

Roskilde, 4000, Denmark

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Plasma, Serum and urine

MeSH Terms

Conditions

Kidney Neoplasms; Adenoma, Oxyphilic

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; Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: September 16, 2021
• First Posted: September 29, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2025
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 30, 2024

Record last verified: 2024-01

Locations

DK (1)