Glycosaminoglycan Scores as Monitoring Biomarkers in Advanced Renal Cell Carcinoma

NCT02732665 | Completed

• 1 other identifier: GAG-RCC-02
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  Baseline; 6 weeks after treatment start

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Untreated patients with diagnosis of metastatic renal cell carcinoma referred for first line treatment.

You may qualify if:

• 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
• Planned for standard imaging within 16 weeks after start of therapy
• Informed consent

You may not qualify if:

• Lack of proper compliance to accept continuous samplings

Sponsors & Collaborators

• Jens Nielsen: lead
• Sahlgrenska University Hospital: collaborator
• University of Modena and Reggio Emilia: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Related Publications (1)

• 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.

  PMID: 36848607 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Ethylenediaminetetraacetic acid (EDTA)-plasma from blood obtained through venipuncture; and any-void urine.

MeSH Terms

Conditions

Carcinoma, Renal Cell

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases

Study Officials

• Jens Nielsen, PhD

  Chalmers University of Technology

  PRINCIPAL INVESTIGATOR

• Ulrika Stierner, M.D. PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: April 11, 2016
• Study Start: June 1, 2016
• Primary Completion: December 1, 2020
• Study Completion: February 1, 2021
• Last Updated: April 5, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)