Cancer Paid Clinical Trials in Virginia

The SHIELD (Screening for High Frequency Malignant Disease) study is a prospective, observational, multi-site basket design trial without randomization. The primary objective of the study is to evaluate the sensitivity and specificity of a blood-based GuardantLUNAR-2 test to detect high frequency cancer in screen-relevant populations. Read Less

This trial is a first-in-human, open label, multi-center, dose escalation phase 1a study followed by a disease-specific dose expansion phase 1b study to evaluate the safety, efficacy, and pharmacokinetics (PK) of IMM2902, a HER2/SIRPα bispecific mAb-Trap antibody-receptor fusion protein, in patients with HER2-expressing advanced solid tumor. Read Less

This is a prospective, single arm, open label, multicenter interventional study designed to evaluate the efficacy of neoadjuvant chemotherapy with anti-HER2 antibodies in patients with HER2-negative invasive breast cancer who have abnormal HER2 signaling activity determined by the Celcuity CELx HER2 Signaling Function (HSF) testing. Read Less

Many patients are treated for advanced cancer without knowledge of underlying molecular features that might indicate FDA approved therapies or potential eligibility for biomarker-selected clinical trials. The Strata Trial (STR-001-001) has been initiated by Strata Oncology to evaluate the clinical benefit of systematic comprehensive genomic profiling for participants with advanced cancer using real-world data and endpoints, while assessing the proportion of participants available for clinical trials and approved targeted therapies in advanced and/or aggressive cancers. The Strata Trial uses surplus, or leftover, tumor specimens for molecular profiling and does not require additional study-specific procedures. Read Less

The objective of this prospective, multi-centre study is to evaluate the performance of ADXBLADDER, a urine MCM5 ELISA test, as an aid in the detection of bladder cancer recurrence. Patients undergoing cystoscopic surveillance in non-muscle invasive bladder cancer (NMIBC) follow-up will be recruited and asked to provide a urine sample to be tested with ADXBLADDER. To assess the diagnostic accuracy of the test, the MCM5 results will be compared with the gold standard cystoscopy and pathology of resected tissue. Read Less

A Phase 2/3 Study of Evorpacept (ALX148) in Combination With Trastuzumab, Ramucirumab, and Paclitaxel in Patients With Advanced HER2-overexpressing gastric/GEJ adenocarcinoma. Read Less

This proposal uses HER2Bi armed activated T-cells (HER2 BATs) to target breast cancer in combination with pembrolizumab (PBZ) in women with metastatic breast cancer (MBC). Phase I will determine a safe dose of the combination of PBZ and HER2 BATs in 3 to 18 patients. In the phase II portion, an additional 12 patients will be treated at the selected dose to further evaluate the safety and preliminary efficacy. Study treatment includes a combination of 8 infusions of BATs using a previously established schedule and one to three infusions of PBZ (200 mg per dose). PBZ will be added to 8 infusions of BATs in 3 schedules: #1) after the 8th BATs infusion; #2) after the 4th and 8th BATs infusions; and then, #3) before the 1st and after the 4th and 8th BATs infusions. Read Less

Bluestar Genomics has developed a non-invasive test that aids in detection of occult pancreatic cancer in patients with new onset type II diabetes (NOD) who are 50 years old or older. The purpose of this study is to evaluate the performance of Bluestar Genomics early-detection pancreatic cancer test in a clinical setting. The study is prospective, longitudinal and interventional; tests will be ordered and results returned to site-investigators. If the test returns a pancreatic cancer signal "detected" result the study participant will undergo MRI imaging to evaluate for the presence of pancreatic cancer. The study is planned to enroll 6,550 newly diagnosed type 2 diabetic subjects according to inclusion and exclusion criteria. Read Less

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy. Condition or disease: Breast Cancer Intervention/treatment: Drug: Gedatolisib Drug: Palbociclib Drug: Fulvestrant Drug: Alpelisib Phase 3 Read Less

A first-in-human study using BIO-106 as a single agent and in combination with pembrolizumab in advanced cancers. Read Less

This is an observational study of voice outcomes in participants following thyroidectomy or another head and neck surgery that does not involve risk to the larynx other than risks incurred due to intubation alone. These comparative (non-thyroidectomy) surgeries would not be expected to interfere with the primary nerves involved with voice production, so they would help to better understand the effect of intubation alone on voice outcomes. Read Less

Partial nephrectomy (PN) is the standard treatment for localized renal masses and should be preferred in clinical T1 (<7 cm tumor diameter) renal tumors over radical nephrectomy (RN) whenever technically feasible. Nonetheless, indications, approaches, techniques for PN, and correct reporting of outcomes, are still a matter of great debate within the urology community. Concurrently, case-report series suggested that alternative strategies for the treatment of localized renal tumors (ablation techniques (AT), watchful waiting (WW), active surveillance (AS)) could be feasible with acceptable oncologic outcomes in particular settings of patients with localized renal tumors. In this complex clinical scenario, the role surgeon-related and environmental factors (such as surgical experience, hospital resources, countries' social background and performance of health system) are important to address the best personalized approach in patients with renal tumors. In the light of current evidence, many unsolved questions still remain and many unmet needs must be addressed. In particular, 1) the risk-benefit trade-offs between PN and RN for anatomically complex renal localized tumors; 2) the definition of evidence-based strategies to tailor the management strategy (AT vs WW vs AS vs surgery) in different subset of patients with particular clinical conditions (i.e. old, frail, comorbid patients); and 3) the definition of evidence-based recommendations to adapt surgical approach (open vs laparoscopic vs robotic) and resection techniques to different patient-, tumor-, and surgeon-specific characteristics. To meet the challenges, to overcome the limitations of current kidney cancer literature (such as the retrospective study design, potential risk of biases, and heterogeneous follow-up of most series), and to provide high-quality evidence for future development of effective clinical practice Guidelines, we designed the international REgistry of COnservative or Radical treatment of localized kiDney tumors (i-RECORD) Project. The expected impact of the i-RECORD project is to provide robust evidence on the leading clinical and environmental factors driving selection of the management strategy in patients with kidney cancer, and the differential impact of different management strategies (including AS, WW, AT, PN and RN) on functional, perioperative and oncological outcomes, as well as quality of life assessment, at a mid-long term follow-up (5-10 years). Read Less