Renal Cancer Detection With Liquid Biopsy (GaGnostic)

January 27, 2024 updated by: Nessn Azawi, Zealand University Hospital
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Roskilde, Denmark, 4000
        • Recruiting
        • Zealand University Hospital
        • Contact:
        • Principal Investigator:
          • Nessn Azawi, Ph.D

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To identify the optimal GAG score
Time Frame: 2 years
To identify the optimal GAG score in RCC patients
2 years
To identify the optimal GAG score
Time Frame: 2 years
To identify the optimal GAG score in oncocytoma
2 years
To identify the optimal GAG score
Time Frame: 2 years
To identify the optimal GAG score in healthy individuel
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zealand University Hospital

Collaborators

Lund University
Elypta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2021

Primary Completion (Estimated)

July 1, 2025

Study Completion (Estimated)

July 1, 2027

Study Registration Dates

First Submitted

September 16, 2021

First Submitted That Met QC Criteria

September 28, 2021

First Posted (Actual)

September 29, 2021

Study Record Updates

Last Update Posted (Actual)

January 30, 2024

Last Update Submitted That Met QC Criteria

January 27, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SJ-894

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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