AUR87A
Research type
Research Study
Full title
Glycosaminoglycan scores for surveillance of recurrence in Leibovich points ≥5 non-metastatic clear cell renal cell carcinoma
IRAS ID
271844
Contact name
Francesco Gatto
Contact email
Sponsor organisation
Elypta AB
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 1 months, 31 days
Research summary
The gold standard for follow up of patients who have undergone surgery for clear cell renal cell carcinoma (ccRCC) is radiological imaging. Still, approximately 30% of the recurrences are found outside the standard radiological follow up. Blood and urine glycosaminoglycans (GAGs) are a promising novel class of biomarkers and GAG scores have shown a potential to be used as a liquid biopsy for post-operative surveillance of RCC.
Th study aims to determine the sensitivity and specificity of GAG scores in detecting RCC recurrence in patients curatively treated for RCC. It is an observational prospective multicenter diagnostic test cohort study. The design is adaptive.
Patients to be enrolled in this study are patients curatively treated for ccRCC. The anticipated minimum number to be enrolled is 280 patients.
The Sponsor of the study is Elypta AB based in Stockholm, Sweden. The initiator and Chief Principal Investigator is Dr. Saeed Dabestani.
Three sites in the United States and thirteen sites in Europe are participating in this study. In total 7 countries will be included. The time to complete all visits for each patient is up to 18 months from inclusion if no recurrence is detected or until a recurrence is detected at imaging follow-up or through tissue biopsy.
REC name
London - Bromley Research Ethics Committee
REC reference
19/LO/1666
Date of REC Opinion
11 Dec 2019
REC opinion
Further Information Favourable Opinion