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OpenTrials
Recruiting

NCT Number: NCT05060783

Renal Cancer Detection With Liquid Biopsy

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Zealand University Hospital

Roskilde, 4000, Denmark

Location status: Recruiting

Location contact

Nessn Azawi, Ph.D

PRINCIPAL_INVESTIGATOR

Nessn H. Azawi, M.D.

CONTACT

[email protected]

004526393034

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

GaGnostic

Diagnostic Test

Plasma

Other names: Glycosaminoglycan

Primary outcomes

  1. To identify the optimal GAG score

    Time frame: 2 years

    To identify the optimal GAG score in RCC patients

  2. To identify the optimal GAG score

    Time frame: 2 years

    To identify the optimal GAG score in oncocytoma

  3. To identify the optimal GAG score

    Time frame: 2 years

    To identify the optimal GAG score in healthy individuel

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Collaborators

  • Elypta
  • Lund University

Registry information

Acronym: GaGnostic

Important dates

Study start
2021
Primary completion
2025
Study completion
2027
First posted
Sep 29, 2021
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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