Glycosaminoglycan Scores as Monitoring Biomarkers in Confined 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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska University Hospital

Gothenburg, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Lack of proper compliance to accept continuous samplings.

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

Recurrence-free survival (RFS)

Time frame: Before surgery

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.

Sponsors and collaborators

Lead sponsor

Chalmers University of Technology

Other

Collaborators

Sahlgrenska University Hospital

Registry information

Official study title

Specificity and Sensitivity of Glycosaminoglycan Scores in the Early Diagnosis of Recurrent Renal Cell Carcinoma

Important dates

Study start: 2016
Primary completion: 2021
Study completion: 2021
First posted: Apr 11, 2016
Registry last updated: Mar 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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