Renal Cancer Detection With Liquid Biopsy

NCT ID: NCT05060783

Last Updated: 2024-01-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-07-01

Study Completion Date

2027-07-01

Brief Summary

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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

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Conditions

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Renal Cancer Oncocytoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Renal Call Carcinoma

Patrients with renal cancer

GaGnostic

Intervention Type DIAGNOSTIC_TEST

Plasma

GaGnostic

Intervention Type DIAGNOSTIC_TEST

Serum

GaGnostic

Intervention Type DIAGNOSTIC_TEST

Urine

Oncocytoma

Patients with oncocytoma

GaGnostic

Intervention Type DIAGNOSTIC_TEST

Plasma

GaGnostic

Intervention Type DIAGNOSTIC_TEST

Serum

GaGnostic

Intervention Type DIAGNOSTIC_TEST

Urine

Healthy persons

Patients with CT scan shows no renal cancer

GaGnostic

Intervention Type DIAGNOSTIC_TEST

Plasma

GaGnostic

Intervention Type DIAGNOSTIC_TEST

Serum

GaGnostic

Intervention Type DIAGNOSTIC_TEST

Urine

Interventions

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GaGnostic

Plasma

Intervention Type DIAGNOSTIC_TEST

GaGnostic

Serum

Intervention Type DIAGNOSTIC_TEST

GaGnostic

Urine

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Glycosaminoglycan Glycosaminoglycan Glycosaminoglycan

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role collaborator

Elypta

INDUSTRY

Sponsor Role collaborator

Zealand University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Nessn Azawi

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Zealand University Hospital

Roskilde, , Denmark

Site Status RECRUITING

Countries

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Denmark

Facility Contacts

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Nessn H. Azawi, M.D.

Role: primary

004526393034

Other Identifiers

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SJ-894

Identifier Type: -

Identifier Source: org_study_id

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