Preliminary results from an independent analysis of the italian cohort of the identify study: Baseline features of italian patients investigated for suspicious urinary tract malignancy at 5 italian tertiary referral centers

Aim of the study: IDENTIFY is an international prospective multicenter study aiming to investigate the management of patients referred for suspicious urinary tract cancers. Our aim was to describe the main features of patients undergoing investigation for suspected urothelial cancer (UC) in Italy. Materials and methods: IDENTIFY project started in December’17, recruiting patients that underwent a cystoscopy to exclude urothelial cancer. We included patients until May 2018. A history of previous urological cancer or a previous cystoscopy were criteria for exclusion. Data were prospectively collected online (redcap.org) from 5 urological departments in Italy. Clinical condition, familial and environmental risk factors (smoking, exposure to chemicals, ongoing drugs), characteristics of hematuria and of urine analysis, blood test and imaging were collected, as well as pathologic reports of UC. Results: Over 618 patients were recorded at the time of analysis. Of these, 181 were excluded because of incomplete results and 437 were finally included. Cystoscopies were performed due to macroscopic and microscopic-hematuria in 73,2% and 6,2% whilst in the remnant 20,6% no hematuria was present. Sex ratio (M/F) was 351/86, mean age was 70 (median 72); 80% of the patients were over 60. The overall incidence for malignant UC was 50,1% (219/437 – 85% TCC); 20,4% (89/437) had benign disease, the remnant 29,5% had irrelevant findings. Malignant UC was more frequent in males, n = 189/351 (53,8% p<,001) and in patients older than 60 n = 185/350 (52,9% p<,02). In current or exsmokers n = 149/252 (59,1%) had a UC diagnosis whilst n = 48/131 nonsmokers (36,6%) had UC (p<,001). The incidence of malignant UC was not influenced by BMI, in the subgroups of BMI ≤25 and ≥ 30 the 48,3% and the 44,4% respectively were found positive for malignancy (p>,05). Among the n = 115 with a positive family history for any cancer, n = 68 (59,1%) developed a malignant UC (p<,001). In the case of hematuria, micro or macroscopic, bladder disease was found in n = 248/347 cases (71,5%), of which 66,5% were confirmed to be malignant. For multiples hematuria episodes, the incidence of malignancy was 51,7% versus 41,5% in case of one single bleeding (p<,001). Interestingly, differences in malign UC incidence between macro and microscopic hematuria were lighter: 47,2% versus 51,9% respectively (p>,05). The most frequent benign causes of hematuria were: 42% prostatic, 19% stones and 15% UTI and among the malignant, the most frequent cancers were: bladder 88%, renal pelvis 4,5% and prostate 3,8%. Table 1 shows the features of the cohort and results of Chi^2 test over the different incidence between groups. Discussion: In this preliminary independent analysis of the Italian cohort of the IDENTIFY study hematuria is undeniably associated with UC, even if benign a cause is frequent. An undelayed check-up of all the urinary tract is mandatory especially in subgroups at a higher incidence of UC. The IDENTIFY study definitive analysis is awaited to confirm our findings.