Glycosaminoglycan Scores as Monitoring Biomarkers in Confined Renal Cell Carcinoma

NCT02732652 | Completed

• 1 other identifier: GAG-RCC-01
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• 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.

  Every 6 or 12 months after surgery up to 5 years

Secondary Outcomes (1)

• Recurrence-free survival (RFS)

  Before surgery

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

Subjects referred for partial or radical nephrectomy for suspicion of renal cell carcinoma

You may qualify if:

• Patients referred for partial or radical nephrectomy for suspicion of renal cell carcinoma
• Predicted life expectancy over 2 months
• Planned for standard imaging within 16 weeks after start of therapy

You may not qualify if:

• Lack of proper compliance to accept continuous samplings.

Sponsors & Collaborators

• Chalmers University of Technology: lead
• Sahlgrenska University Hospital: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Related Publications (1)

• 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.

  PMID: 35911082 RESULT

Related Links

• Related Info

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

• Sven Lundstam, M.D. PhD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 16, 2016
• First Posted: April 11, 2016
• Study Start: June 1, 2016
• Primary Completion: May 1, 2021
• Study Completion: September 1, 2021
• Last Updated: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share

Locations

SE (1)