Carcinoma, Renal CellNCT02732665
Glycosaminoglycan Scores as Monitoring Biomarkers in Advanced Renal Cell Carcinoma
An observational study of Carcinoma, Renal Cell, run by Jens Nielsen at 1 site in Sweden.
Trial summary
In this study, glycosaminoglycan (GAG) profiling in subjects diagnosed with metastatic renal cell carcinoma (mRCC) is hypothesized to be useful in monitoring drug response and predict radiological response. 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
- 50 participants
- Where
- 1 siteSweden
- Study dates
- Jun 2016to Feb 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: Untreated patients with diagnosis of metastatic renal cell carcinoma referred for first line treatment.
Who may be able to join
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Diagnosis of renal cell carcinoma
- Metastatic disease
- Predicted life expectancy over 2 months
- Patient referred for first line drug therapy
- Standard imaging evaluation 12 weeks prior to inclusion
- Planned for standard imaging within 16 weeks after start of therapy
- Informed consent
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: Sensitivity and Specificity of Glycosaminoglycan Scores in the Diagnosis of Early Progression in Advanced Renal Cell Carcinoma
In this study, glycosaminoglycan (GAG) profiling in subjects diagnosed with metastatic renal cell carcinoma (mRCC) is hypothesized to be useful in monitoring drug response and predict radiological response. To this end, glycosaminoglycan scores based on longitudinal samples of plasma and urine in prospectively enrolled patients will be correlated to radiological response to first-line therapy based on current standard-of-care. A positive correlation indicates that glycosaminoglycan scores can successfully detect patients that are not responding to treatment before the scheduled follow-up in which radiological imaging is performed. Data on the extent of metastasis (number of metastatic sites) will be collected to assess whether glycosaminoglycans correlate accordingly.
- 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 to progressive disease at response evaluation
ROC curves are generated to determine the specificity and sensitivity of the glycosaminoglycan scores sampled at 6 weeks and every 3 months to progressive disease as assessed by radiological imaging during the scheduled response evaluation according to RECIST 1.1. criteria. The area under each ROC curve (AUC) is then calculated as primary outcome measure.
Measured: 6 weeks and every 3 months after treatment start up to 12 months
Secondary outcomes (1)
Area under the receiver operating characteristic (ROC) curve (AUC) for the sensitivity/specificity of plasma/urine glycosaminoglycan scores in early prediction of objective response at first response evaluation
ROC curves are generated to determine the specificity and sensitivity of the glycosaminoglycan scores sampled at 6 weeks to complete response or partial response as assessed by radiological imaging during the first scheduled response evaluation according to RECIST 1.1. criteria. The area under each ROC curve (AUC) is then calculated as primary outcome measure.
Measured: Baseline; 6 weeks after treatment start
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 completionDec 2020
- Study completionFeb 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
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jens Nielsen
- Sponsor type
- University, hospital or other
- Collaborators
- Sahlgrenska University Hospital, University of Modena and Reggio Emilia
- Responsible party
- Sponsor-investigator, Jens Nielsen, Chalmers University of Technology
- Investigators
- Jens Nielsen, PhD, Principal investigator, Chalmers University of TechnologyUlrika Stierner, M.D. PhD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02732665
- Sponsor's protocol ID
- GAG-RCC-02
- Status last verified
- Apr 2023
- First submitted
- 16 Mar 2016
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Data will be accessible upon study publication
Publications
Gatto F, Bratulic S, Jonasch E, Limeta A, Maccari F, Galeotti F, Volpi N, Lundstam S, Nielsen J, Stierner U. Plasma and Urine Free Glycosaminoglycans as Monitoring and Predictive Biomarkers in Metastatic Renal Cell Carcinoma: A Prospective Cohort Study. JCO Precis Oncol. 2023 Feb;7:e2200361. doi: 10.1200/PO.22.00361.
PubMed 36848607
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Specificity of Glycosaminoglycan Scores in the Diagnosis of Early Progression in Advanced Renal Cell Carcinoma
- ClinicalTrials.gov ID
- NCT02732665
- Acronym / sponsor ID
- GAG-RCC-02
- Conditions
- Carcinoma, Renal Cell
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Jens NielsenUniversity, hospital or other
- Collaborators
- Sahlgrenska University Hospital, University of Modena and Reggio Emilia
- Study start
- Jun 2016 (actual)
- Primary completion
- Dec 2020 (actual)
- Study completion
- Feb 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, glycosaminoglycan (GAG) profiling in subjects diagnosed with metastatic renal cell carcinoma (mRCC) is hypothesized to be useful in monitoring drug response and predict radiological response. To this end, glycosaminoglycan scores based on longitudinal samples of plasma and urine in prospectively enrolled patients will be correlated to radiological response to first-line therapy based on current standard-of-care. A positive correlation indicates that glycosaminoglycan scores can successfully detect patients that are not responding to treatment before the scheduled follow-up in which radiological imaging is performed. Data on the extent of metastasis (number of metastatic sites) will be collected to assess whether glycosaminoglycans correlate accordingly.
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
- Untreated patients with diagnosis of metastatic renal cell carcinoma referred for first line treatment.
Key inclusion criteria (8 listed)
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- Diagnosis of renal cell carcinoma
- Metastatic disease
- Predicted life expectancy over 2 months
- Patient referred for first line drug 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 to progressive disease at response evaluation
Time frame: 6 weeks and every 3 months after treatment start up to 12 months
ROC curves are generated to determine the specificity and sensitivity of the glycosaminoglycan scores sampled at 6 weeks and every 3 months to progressive disease as assessed by radiological imaging during the scheduled response evaluation according to RECIST 1.1. criteria. The area under each ROC curve (AUC) is then calculated as primary outcome measure.
1 secondary outcome
Area under the receiver operating characteristic (ROC) curve (AUC) for the sensitivity/specificity of plasma/urine glycosaminoglycan scores in early prediction of objective response at first response evaluation
Time frame: Baseline; 6 weeks after treatment start
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 5 Apr 2023.
- Results publication: PubMed 36848607Gatto F, Bratulic S, Jonasch E, Limeta A, Maccari F, Galeotti F, Volpi N, Lundstam S, Nielsen J, Stierner U. Plasma and Urine Free Glycosaminoglycans as Monitoring and Predictive Biomarkers in Metastatic Renal Cell Carcinoma: A Prospective Cohort Study. JCO Precis Oncol. 2023 Feb;7:e2200361. doi: 10.1200/PO.22.00361.
- 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
Ulrika Stierner, 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 Jens Nielsen 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 8 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 5 Apr 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 to progressive disease at response evaluation (time frame: 6 weeks and every 3 months after treatment start up to 12 months). 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 NCT02732665, 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 5 Apr 2023.