Clinical trials

The Targeted Agent and Profiling Utilization Registry (TAPUR) Study is a non-randomized clinical trial that aims to describe the performance (both safety and efficacy) of commercially available, targeted anticancer drugs prescribed for treatment of patients with advanced cancer that has a potentially actionable genomic variant. The study provides approved targeted therapies that are contributed to the program by collaborating pharmaceutical companies, catalogues the choice of genomic profiling test by clinical oncologists and aims to learn about the utility of registry data to develop hypotheses for additional clinical trials.

This research study is designed to better understand the molecular determinants of response to immunotherapies including pembrolizumab and nivolumab. We hope to learn the relevance of tumor neoantigens in the recognition of cancer cells by the immune system. The ultimate goal is to rank and filter these neoantigens and correlate with response to immunotherapies.

The study is designed to assess the elasticity of pelvic floor muscles in women with varying degree of pelvic organ prolapse.

Mitral valvular disease, and specifically mitral valve regurgitation is the most common valve disease in the US. Currently mitral valve surgery (open heart surgery), either with repair or replacement, is the standard of care for patients with symptomatic mitral valve disease. Transcatheter mitral valve replacement (TMVR) is an emerging therapy that could offer patient a less invasive alternative to open heart surgery. The goal of the APOLLO trial is to evaluate whether TMVR is non-inferior to conventional mitral surgery with respect to composite endpoint rate of all-cause mortality, all stroke, reoperation (or reintervention) and cardiovascular hospitalization at one year in patients with severe symptomatic native mitral regurgitation. The secondary objectives of this trial are to assess differences in quality of life, clinical benefit (efficacy endpoints) and health economics in patients with severe symptomatic native mitral regurgitation.

Clostridium difficile infection is an intestinal infection that can be life threatening. The incidence is increasing in children, and there is resistance to standard treatment with rising rates of recurrence. In resistant and recurrent cases, manipulation of the microbiome by FMT is an effective treatment. We are examining the intestinal microbiome in children before and after FMT to gain and better understanding of why this treatment is effective and also to improve FMT treatment in the future.

While Caesarean section (CS) delivery can be lifesaving for both new mothers and their babies, children born by CS have an approximately 50 percent increased risk of childhood obesity, along with asthma and allergies. It is believed that the risk of diseases associated with CS delivery may be due to the lack of mother-to-newborn transfer of beneficial vaginal microbes at birth, which are known to play a role in immune and metabolic development.

"Vaginal microbiome seeding,” the transfer of vaginal microbes from mother to baby, is a process that can restore the exposure of a CS-delivered newborn to their mother’s beneficial vaginal microbes. In a pilot study, vaginal microbiome seeding of CS- delivered newborns was associated with an increased abundance of bacteria typically missing or reduced in CS. However, this study was too small to determine effects on early childhood health outcomes such as obesity.

At the Inova Translational Medicine Institute (ITMI) we are conducting the first randomized controlled trial in vaginal microbiome seeding in newborns delivered by CS. ITMI will thoroughly document each baby’s health throughout his or her first three years of life to fully examine microbiome development and childhood health outcomes through regular stool samples and health screenings. If vaginal microbiome seeding is shown to decrease the risk of adverse childhood health outcomes in newborns born by CS, this could improve the health of our children and change the practice of obstetrics as we know it.

Genome Transplant Dynamics (GRAFT)

Gene Expression Profiling of Lung Explant and Biopsy Tissue in Subjects with Advanced Lung Disease

Collection and Storage of Blood/Biospecimens for Research in Patients Referred to the Inova Advanced Lung Disease Program