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GaGnostic: Renal Cancer Detection With Liquid Biopsy

Sponsor
Zealand University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05060783
Collaborator
Lund University (Other), Elypta (Industry)
200
Enrollment
1
Location
24
Anticipated Duration (Months)
8.3
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: GaGnostic
  • Diagnostic Test: GaGnostic
  • Diagnostic Test: GaGnostic

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Renal Cancer Detection With Liquid Biopsy
Actual Study Start Date :
Jul 1, 2021
Anticipated Primary Completion Date :
Jul 1, 2023
Anticipated Study Completion Date :
Jul 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Renal Call Carcinoma

Patrients with renal cancer

Diagnostic Test: GaGnostic
Plasma
Other Names:
  • Glycosaminoglycan

    • Diagnostic Test: GaGnostic
    Serum
    Other Names:
  • Glycosaminoglycan

    • Diagnostic Test: GaGnostic
    Urine
    Other Names:
  • Glycosaminoglycan

    		•
    Oncocytoma

    Patients with oncocytoma

    Diagnostic Test: GaGnostic
    Plasma
    Other Names:
  • Glycosaminoglycan

    • Diagnostic Test: GaGnostic
    Serum
    Other Names:
  • Glycosaminoglycan

    • Diagnostic Test: GaGnostic
    Urine
    Other Names:
  • Glycosaminoglycan

    		•
    Healthy persons

    Patients with CT scan shows no renal cancer

    Diagnostic Test: GaGnostic
    Plasma
    Other Names:
  • Glycosaminoglycan

    • Diagnostic Test: GaGnostic
    Serum
    Other Names:
  • Glycosaminoglycan

    • Diagnostic Test: GaGnostic
    Urine
    Other Names:
  • Glycosaminoglycan

    		•

    Outcome Measures

    Primary Outcome Measures

    1. To identify the optimal GAG score [2 years]

      To identify the optimal GAG score in RCC patients

    2. To identify the optimal GAG score [2 years]

      To identify the optimal GAG score in oncocytoma

    3. To identify the optimal GAG score [2 years]

      To identify the optimal GAG score in healthy individuel

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zealand University Hospital Roskilde Denmark 4000

    Sponsors and Collaborators

    • Zealand University Hospital
    • Lund University
    • Elypta

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Nessn Azawi, Associate professor, Zealand University Hospital
    ClinicalTrials.gov Identifier:
    NCT05060783
    Other Study ID Numbers:
    • SJ-894
    First Posted:
    Sep 29, 2021
    Last Update Posted:
    Jan 3, 2022
    Last Verified:
    Dec 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Kidney Neoplasms
    Carcinoma, Renal Cell
    Adenoma, Oxyphilic

    Study Results

    No Results Posted as of Jan 3, 2022