Renal Cell CarcinomaNCT03471897
Plasma Glycosaminoglycans as Diagnostic and Prognostic Biomarkers in Surgically Treated Renal Cell Carcinoma
An observational study of Renal Cell Carcinoma, run by Chalmers University of Technology.
Trial summary
In this study, the investigators profiled plasma glycosaminoglycans (GAGs) in a retrospective consecutive series of patients with a radiographic finding of renal mass referred to primary surgery for renal cell carcinoma (RCC). A control group was formed by measuring plasma GAGs in healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- Glycosaminoglycan plasma score
- How many people
- 237 participants
- Where
- No sites listed yet
- Study dates
- 28 Apr 2016to 18 Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with pathologically confirmed diagnosis of RCC treated with surgical resection of the tumor
Who may be able to join
- Patients with radiographic finding of renal mass referred to primary surgery;
- Healthy volunteers without any history of malignancy.
Who cannot join
- No records on date of surgery;
- A pre-operative sample was obtained 50 days or earlier with respect to the date of surgery; - Absence of pre-operative samples following filtering out outliers or laboratory assay failures.
About this study
In this study, the investigators profiled plasma glycosaminoglycans (GAGs) in a retrospective consecutive series of patients with a radiographic finding of renal mass referred to primary surgery for renal cell carcinoma (RCC). A control group was formed by measuring plasma GAGs in healthy volunteers. The primary endpoints were the specificity and sensitivity of plasma GAGs in the detection of early stage RCC in pre-surgical samples versus healthy individuals. The investigators further analyzed how plasma GAGs varied according to stage, grade, RCC histology, other renal masses, and after surgery. Finally, the investigators estimated whether plasma GAGs could be used for prediction and surveillance of RCC recurrence.
- Conditions
- Renal Cell Carcinoma
- Being tested
- Glycosaminoglycan plasma score
- Keywords
- glycosaminoglycans, biomarkers, diagnostics, prognostic, liquid biopsy
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glycosaminoglycan plasma scoreDiagnostic test
A score was calculated using a formula that factors in measurements of plasma glycosaminoglycan. A score higher than a here-determined threshold is deemed diagnostic of RCC.
| Study group | Role | What they receive |
|---|---|---|
| RCC | Patients with pathologically confirmed diagnosis of RCC Receives: Diagnostic Test: Glycosaminoglycan plasma score | |
| Controls | Subjects self-reported as healthy Receives: Diagnostic Test: Glycosaminoglycan plasma score |
What is being measured
The primary outcome is the main question the study is designed to answer.
Specificity and sensitivity of plasma GAGs in the detection of low stage RCC in pre-surgical samples versus healthy individuals
Measured: 1 month
Secondary outcomes (6)
Pearson correlation coefficient with plasma GAG score in pre-surgical samples and tumor size in cm
Measured: 1 month
Shift in plasma GAG score in pre-surgical samples between locally-advanced or advanced vs. localized RCC
The shift is the absolute difference plasma GAG score, which is measured in arbitrary units in the range 0 to +Inf with higher values associated with RCC versus healthy status.
Measured: 1 month
Shift in plasma GAG score in pre-surgical samples between Fuhrman Nuclear Grade 3+ vs. 2 in clear cell RCC.
The shift is the absolute difference plasma GAG score, which is measured in arbitrary units in the range 0 to +Inf with higher values associated with RCC versus healthy status.
Measured: 1 month
Shift in plasma GAG score in pre-surgical samples between clear cell vs. non-clear cell RCC
The shift is the absolute difference plasma GAG score, which is measured in arbitrary units in the range 0 to +Inf with higher values associated with RCC versus healthy status.
Measured: 1 month
Hazard ratio of plasma GAG score dichotomized in "Low" vs. "High" score in pre-surgical samples for overall survival in RCC
The dichotomized plasma GAG score is a categorical binary variable based on a post-hoc cut-off value for the plasma GAG score, which is measured in arbitrary units in the range 0 to +Inf with higher values associated with RCC versus healthy status.
Measured: 53 months
Hazard ratio of plasma GAG score dichotomized in "Low" vs. "High" score in pre-surgical samples for metastatic recurrence-free survival in RCC
The dichotomized plasma GAG score is a categorical binary variable based on a post-hoc cut-off value for the plasma GAG score, which is measured in arbitrary units in the range 0 to +Inf with higher values associated with RCC versus healthy status.
Measured: 53 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2018
- Study start28 Apr 2016
- Primary completion25 Oct 2017
- Study completion18 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Renal Cell CarcinomaStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chalmers University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03471897
- Sponsor's protocol ID
- GAG-RCC-03
- Status last verified
- Apr 2018
- First submitted
- 14 Mar 2018
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gatto F, Blum KA, Hosseini SS, Ghanaat M, Kashan M, Maccari F, Galeotti F, Hsieh JJ, Volpi N, Hakimi AA, Nielsen J. Plasma Glycosaminoglycans as Diagnostic and Prognostic Biomarkers in Surgically Treated Renal Cell Carcinoma. Eur Urol Oncol. 2018 Oct;1(5):364-377. doi: 10.1016/j.euo.2018.04.015. Epub 2018 Jun 13.
PubMed 31158075
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Plasma Glycosaminoglycans as Diagnostic and Prognostic Biomarkers in Surgically Treated Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT03471897
- Acronym / sponsor ID
- GAG-RCC-03
- Conditions
- Renal Cell Carcinoma
- Keywords
- glycosaminoglycans, biomarkers, diagnostics, prognostic, liquid biopsy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Chalmers University of TechnologyUniversity, hospital or other
- Collaborators
- Memorial Sloan Kettering Cancer Center
- Study start
- 28 Apr 2016 (actual)
- Primary completion
- 25 Oct 2017 (actual)
- Study completion
- 18 Jan 2018 (actual)
- First posted
- 21 Mar 2018 (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.
In this study, the investigators profiled plasma glycosaminoglycans (GAGs) in a retrospective consecutive series of patients with a radiographic finding of renal mass referred to primary surgery for renal cell carcinoma (RCC). A control group was formed by measuring plasma GAGs in healthy volunteers. The primary endpoints were the specificity and sensitivity of plasma GAGs in the detection of early stage RCC in pre-surgical samples versus healthy individuals. The investigators further analyzed how plasma GAGs varied according to stage, grade, RCC histology, other renal masses, and after surgery. Finally, the investigators estimated whether plasma GAGs could be used for prediction and surveillance of RCC recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RCC | – | Diagnostic Test: Glycosaminoglycan plasma scorePatients with pathologically confirmed diagnosis of RCC |
| Controls | – | Diagnostic Test: Glycosaminoglycan plasma scoreSubjects self-reported as healthy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with pathologically confirmed diagnosis of RCC treated with surgical resection of the tumor
Key inclusion criteria (2 listed)
- Patients with radiographic finding of renal mass referred to primary surgery;
- Healthy volunteers without any history of malignancy.
Key exclusion criteria (2 listed)
- No records on date of surgery;
- A pre-operative sample was obtained 50 days or earlier with respect to the date of surgery; - Absence of pre-operative samples following filtering out outliers or laboratory assay failures.
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 |
|---|---|---|
| Glycosaminoglycan plasma scoreA score was calculated using a formula that factors in measurements of plasma glycosaminoglycan. A score higher than a here-determined threshold is deemed diagnostic of RCC. | Diagnostic test | Controls, RCC |
Primary outcome
Specificity and sensitivity of plasma GAGs in the detection of low stage RCC in pre-surgical samples versus healthy individuals
Time frame: 1 month
6 secondary outcomes
Pearson correlation coefficient with plasma GAG score in pre-surgical samples and tumor size in cm
Time frame: 1 month
Shift in plasma GAG score in pre-surgical samples between locally-advanced or advanced vs. localized RCC
Time frame: 1 month
Shift in plasma GAG score in pre-surgical samples between Fuhrman Nuclear Grade 3+ vs. 2 in clear cell RCC.
Time frame: 1 month
Shift in plasma GAG score in pre-surgical samples between clear cell vs. non-clear cell RCC
Time frame: 1 month
Hazard ratio of plasma GAG score dichotomized in "Low" vs. "High" score in pre-surgical samples for overall survival in RCC
Time frame: 53 months
Hazard ratio of plasma GAG score dichotomized in "Low" vs. "High" score in pre-surgical samples for metastatic recurrence-free survival in RCC
Time frame: 53 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Derived from this study: PubMed 31158075Gatto F, Blum KA, Hosseini SS, Ghanaat M, Kashan M, Maccari F, Galeotti F, Hsieh JJ, Volpi N, Hakimi AA, Nielsen J. Plasma Glycosaminoglycans as Diagnostic and Prognostic Biomarkers in Surgically Treated Renal Cell Carcinoma. Eur Urol Oncol. 2018 Oct;1(5):364-377. doi: 10.1016/j.euo.2018.04.015. Epub 2018 Jun 13.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Cell Carcinoma, run by Chalmers University of Technology.
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 2 inclusion and 2 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: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Specificity and sensitivity of plasma GAGs in the detection of low stage RCC in pre-surgical samples versus healthy individuals (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03471897, which also lists 1 linked publication.
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 17 Apr 2018.