Renal CancerGaGnosticNCT05060783
Renal Cancer Detection With Liquid Biopsy
An observational study of Renal Cancer and Oncocytoma, run by Zealand University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cancer, Oncocytoma
- What is being tested?
- GaGnostic
- How many people
- 200 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jul 2021to 1 Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Zealand University Hospital
Roskilde, 4000
Nessn H. Azawi, M.D., 004526393034, nesa@regionsjaelland.dk
Nessn Azawi, Ph.D
About this study
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
- Being tested
- GaGnostic
- Medical subject headings
- Kidney Neoplasms, Adenoma, Oxyphilic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GaGnosticDiagnostic test
Also called Glycosaminoglycan
Plasma
GaGnosticDiagnostic test
Also called Glycosaminoglycan
Serum
GaGnosticDiagnostic test
Also called Glycosaminoglycan
Urine
| Study group | Role | What they receive |
|---|---|---|
| Renal Call Carcinoma | Patrients with renal cancer Receives: Diagnostic Test: GaGnostic | |
| Oncocytoma | Patients with oncocytoma Receives: Diagnostic Test: GaGnostic | |
| Healthy persons | Patients with CT scan shows no renal cancer Receives: Diagnostic Test: GaGnostic |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the optimal GAG score
To identify the optimal GAG score in RCC patients
Measured: 2 years
To identify the optimal GAG score
To identify the optimal GAG score in oncocytoma
Measured: 2 years
To identify the optimal GAG score
To identify the optimal GAG score in healthy individuel
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2021
- Study start1 Jul 2021
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CancerStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Lund University, Elypta
- Responsible party
- Principal investigator, Nessn Azawi, Zealand University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05060783
- Sponsor's protocol ID
- SJ-894
- Acronym
- GaGnostic
- Status last verified
- Jan 2024
- First submitted
- 16 Sep 2021
- Last updated
- 30 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Renal Cancer Detection With Liquid Biopsy
- ClinicalTrials.gov ID
- NCT05060783
- Acronym / sponsor ID
- GaGnostic / SJ-894
- Conditions
- Renal Cancer, Oncocytoma
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Collaborators
- Lund University, Elypta
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 29 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Renal Call Carcinoma | – | Diagnostic Test: GaGnosticPatrients with renal cancer |
| Oncocytoma | – | Diagnostic Test: GaGnosticPatients with oncocytoma |
| Healthy persons | – | Diagnostic Test: GaGnosticPatients with CT scan shows no renal cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GaGnosticAlso: GlycosaminoglycanPlasma | Diagnostic test | Healthy persons, Oncocytoma, Renal Call Carcinoma |
| GaGnosticAlso: GlycosaminoglycanSerum | Diagnostic test | Healthy persons, Oncocytoma, Renal Call Carcinoma |
| GaGnosticAlso: GlycosaminoglycanUrine | Diagnostic test | Healthy persons, Oncocytoma, Renal Call Carcinoma |
Primary outcome
To identify the optimal GAG score
Time frame: 2 years
To identify the optimal GAG score in RCC patients
To identify the optimal GAG score
Time frame: 2 years
To identify the optimal GAG score in oncocytoma
To identify the optimal GAG score
Time frame: 2 years
To identify the optimal GAG score in healthy individuel
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cancer and Oncocytoma, run by Zealand University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To identify the optimal GAG score (time frame: 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2024.