Clinical Research Directory

Screening for Urological Malignancies Using a Urine Exfoliated Cell Fluorescence Assay in a Hematuria Population

This is a prospective, single-center diagnostic clinical study designed to evaluate the performance of a urine-based immunofluorescence cytology test for the detection of urological malignancies in patients presenting with hematuria. The study will enroll 170 eligible participants who are scheduled for cystoscopy and/or ureteroscopy. Urine samples will be collected prior to endoscopy and subjected to both the index immunofluorescence assay and DNA ploidy analysis, with the results compared against the reference standard of endoscopic biopsy and histopathology. The primary objective is to estimate the sensitivity, specificity, and negative predictive value of the immunofluorescence test. Secondary objectives include evaluating the diagnostic accuracy of DNA ploidy analysis, comparing the two index tests using paired statistical methods (e.g., McNemar's test), and assessing their agreement with the reference standard via Kappa statistics. Sample size calculation, based on an assumed malignancy rate of 15% and a target of at least 23 pathology-confirmed malignant cases, ensures adequate power for the primary comparison. The study will follow standardized operating procedures, with independent, blinded interpretation by trained cytopathologists. Statistical analyses will be performed using R or SPSS, with a two-sided significance level of 0.05. The trial is scheduled to commence in April 2026 and is expected to conclude by June 2027, with the aim of providing evidence for a non-invasive, rapid, and cost-effective screening tool in hematuria populations.

A Study of Atezolizumab in Combination With Epacadostat in Subjects With Previously Treated Stage IIIB or Stage IV Non-Small Cell Lung Cancer and Previously Treated Stage IV Urothelial Carcinoma

This study evaluated the safety and tolerability of epacadostat (INCB024360) administered in combination with atezolizumab (MPDL3280A) in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) that were previously treated with platinum-based chemotherapy and Stage IV urothelial carcinoma who failed a platinum-based chemotherapy regimen. The study was conducted in two phases. The dose escalation phase did utilize a 3 + 3 design to identify the maximum tolerated dose (MTD) or a Pharmacologically Active Dose (PAD) of the combination. This was followed by a dose expansion phase, which was comprised of three cohorts. Expansion Cohorts 1 \& 2 will further evaluate the safety, tolerability, efficacy, pharmacokinetics (PK), and pharmacodynamics at the dose identified in phase one. Expansion Cohort 3 will evaluate the change in biomarker expression following treatment with epacadostat as monotherapy followed by epacadostat and atezolizumab administered in combination.

Study of DECOY20 With or Without Tislelizumab in Patients With Advanced Solid Tumors

INDP-D101 is a Phase 1/2, open-label, multi-center, dose escalation and expansion study evaluating the safety, tolerability and clinical activity of Decoy20 as monotherapy and in combination with tislelizumab in patients with locally advanced or metastatic solid tumors.

A Comparative Study of Neoadjuvant Chemotherapy Versus Upfront Radical Surgery for Upper Tract Urothelial Carcinoma

This is a single-center, open-label, non-randomized controlled trial comparing the efficacy and safety of neoadjuvant chemotherapy (NAC) followed by radical surgery versus upfront radical surgery alone in patients with high-risk, non-metastatic upper tract urothelial carcinoma (UTUC). The study aims to answer the following key questions: Does NAC improve pathologic response rates (defined as downstaging to \<ypT2N0) compared to immediate surgery? What is the rate of pathologic complete response (pCR; ypT0N0) in the NAC group? How do the two treatment strategies compare in terms of overall survival, cancer-specific survival, and recurrence-free survival? What is the safety and tolerability profile of NAC using gemcitabine and cisplatin in this patient population? Eligible participants will be assigned to either the NAC-plus-surgery group or the surgery-only group based on clinical evaluation and patient preference. The study will also explore potential biomarkers (e.g., chromosomal instability in liquid biopsies) for predicting treatment response. Key Eligibility Criteria: Adults with histologically confirmed high-risk UTUC Clinical stage ≤N1 M0 Adequate renal function (GFR ≥45 mL/min) and ECOG performance status 0-1 Primary Outcome: Pathologic response rate (proportion of patients with \<ypT2N0)