Carcinoma, Renal CellNCT02732652
Glycosaminoglycan Scores as Monitoring Biomarkers in Confined Renal Cell Carcinoma
An observational study of Carcinoma, Renal Cell, run by Chalmers University of Technology at 1 site in Sweden.
Trial summary
In this study, a score based on glycosaminoglycan (GAG) profiling in subjects with suspicion of renal cell carcinoma (RCC) is hypothesized to distinguish malignant masses when early actionable clinical decisions are desirable. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Renal Cell
- How many people
- 72 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2016to Sep 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Subjects referred for partial or radical nephrectomy for suspicion of renal cell carcinoma
Who may be able to join
- Patients referred for partial or radical nephrectomy for suspicion of renal cell carcinoma
- Predicted life expectancy over 2 months
- Standard imaging evaluation 12 weeks prior to inclusion
- Planned for standard imaging within 16 weeks after start of therapy
Who cannot join
- Lack of proper compliance to accept continuous samplings.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Specificity and Sensitivity of Glycosaminoglycan Scores in the Early Diagnosis of Recurrent Renal Cell Carcinoma
In this study, a score based on glycosaminoglycan (GAG) profiling in subjects with suspicion of renal cell carcinoma (RCC) is hypothesized to distinguish malignant masses when early actionable clinical decisions are desirable. For example to diagnose early recurrence after surgical treatment; to screen population at risk of RCC; or to distinguish benign masses from RCC before surgical treatment. To this end, plasma and urine GAGs will be measured in a prospective cohort of patients referred to surgical treatment for RCC. The resulting GAG scores are then correlated to post-surgical recurrence, to post-surgical definitive diagnosis and and to tumor size if RCC. In a subset cohort of patients at high risk of RCC recurrence, plasma and urine GAGs will be monitored to observe its correlation with disease recurrence.
- Conditions
- Carcinoma, Renal Cell
- Medical subject headings
- Carcinoma, Renal Cell
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the receiver operating characteristic (ROC) curve (AUC) for the sensitivity/specificity of plasma/urine glycosaminoglycan scores in the prediction of renal cell carcinoma recurrence after surgery
Radiological assessment of patients with definitive diagnosis of RCC and classified as high risk will be carried out as standard-of-care during follow-up and subjected to correlative analysis relative to the plasma/urine glycosaminoglycan scores (or their change) as assessed by longitudinal sampling.
Measured: Every 6 or 12 months after surgery up to 5 years
Secondary outcomes (1)
Recurrence-free survival (RFS)
Survival analysis will be performed by Kaplan Meier and significance analysis will use the log-rank test. Cox multivariate analysis will be performed to look at the number and molecular characteristics of the glycosaminoglycan scores as independent prognostic parameters of survival.
Measured: Before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2016 (estimated)
- Study startJun 2016
- Primary completionMay 2021
- Study completionSep 2021
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 Carcinoma, Renal CellStudies 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
- Prospective
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chalmers University of Technology
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Responsible party
- Principal investigator, Jens Nielsen, Chalmers University of Technology
- Investigators
- Jens Nielsen, PhD, Principal investigator, Chalmers University of TechnologySven Lundstam, M.D. PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732652
- Sponsor's protocol ID
- GAG-RCC-01
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2016
- Last updated
- 22 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be accessible upon study publication
Publications
Gatto F, Dabestani S, Bratulic S, Limeta A, Maccari F, Galeotti F, Volpi N, Stierner U, Nielsen J, Lundstam S. Plasma and Urine Free Glycosaminoglycans as Monitoring Biomarkers in Nonmetastatic Renal Cell Carcinoma-A Prospective Cohort Study. Eur Urol Open Sci. 2022 Jun 29;42:30-39. doi: 10.1016/j.euros.2022.06.003. eCollection 2022 Aug.
PubMed 35911082
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specificity and Sensitivity of Glycosaminoglycan Scores in the Early Diagnosis of Recurrent Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02732652
- Acronym / sponsor ID
- GAG-RCC-01
- Conditions
- Carcinoma, Renal Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Chalmers University of TechnologyUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital
- Study start
- Jun 2016
- Primary completion
- May 2021 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 11 Apr 2016 (estimated)
- 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, a score based on glycosaminoglycan (GAG) profiling in subjects with suspicion of renal cell carcinoma (RCC) is hypothesized to distinguish malignant masses when early actionable clinical decisions are desirable. For example to diagnose early recurrence after surgical treatment; to screen population at risk of RCC; or to distinguish benign masses from RCC before surgical treatment. To this end, plasma and urine GAGs will be measured in a prospective cohort of patients referred to surgical treatment for RCC. The resulting GAG scores are then correlated to post-surgical recurrence, to post-surgical definitive diagnosis and and to tumor size if RCC. In a subset cohort of patients at high risk of RCC recurrence, plasma and urine GAGs will be monitored to observe its correlation with disease recurrence.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects referred for partial or radical nephrectomy for suspicion of renal cell carcinoma
Key inclusion criteria (4 listed)
- Patients referred for partial or radical nephrectomy for suspicion of renal cell carcinoma
- Predicted life expectancy over 2 months
- Standard imaging evaluation 12 weeks prior to inclusion
- Planned for standard imaging within 16 weeks after start of therapy
Key exclusion criteria (1 listed)
- Lack of proper compliance to accept continuous samplings.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Area under the receiver operating characteristic (ROC) curve (AUC) for the sensitivity/specificity of plasma/urine glycosaminoglycan scores in the prediction of renal cell carcinoma recurrence after surgery
Time frame: Every 6 or 12 months after surgery up to 5 years
Radiological assessment of patients with definitive diagnosis of RCC and classified as high risk will be carried out as standard-of-care during follow-up and subjected to correlative analysis relative to the plasma/urine glycosaminoglycan scores (or their change) as assessed by longitudinal sampling.
1 secondary outcome
Recurrence-free survival (RFS)
Time frame: Before surgery
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 22 Mar 2023.
- Results publication: PubMed 35911082Gatto F, Dabestani S, Bratulic S, Limeta A, Maccari F, Galeotti F, Volpi N, Stierner U, Nielsen J, Lundstam S. Plasma and Urine Free Glycosaminoglycans as Monitoring Biomarkers in Nonmetastatic Renal Cell Carcinoma-A Prospective Cohort Study. Eur Urol Open Sci. 2022 Jun 29;42:30-39. doi: 10.1016/j.euros.2022.06.003. eCollection 2022 Aug.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be accessible upon study publication
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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.
Jens Nielsen, PhD principal investigator
Chalmers University of Technology
Sven Lundstam, M.D. PhD principal investigator
Sahlgrenska University Hospital
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 Carcinoma, Renal Cell, run by Chalmers University of Technology at 1 site in Sweden.
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 1 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 22 Mar 2023. 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 Sweden. 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?
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?
Area under the receiver operating characteristic (ROC) curve (AUC) for the sensitivity/specificity of plasma/urine glycosaminoglycan scores in the prediction of renal cell carcinoma recurrence after surgery (time frame: Every 6 or 12 months after surgery up to 5 years). 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 NCT02732652, 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 22 Mar 2023.