Explore externally sponsored studies at the Otolaryngology Research Program below.
Head and Neck Oncology
Impacting the Oral HPV Continuum: MOUTH Study (Men and Women Offering Understanding of Throat HPV)
GCO#: 18-0175
STUDY: 17-01262
Principle Investigator: Mohemmed Khan, MD
Study Manager: Alecia Charles, MPH
Study Summary: The factors, mechanisms, or timing for persistence and progression of Human Papilloma Virus (HPV), the major cause of oropharyngeal cancer (OPC) in the US, is not fully understood. The objective of this study is to explore the effects of certain risk factors for persistent oral HPV. These behavioral and biologic risk factors include tobacco use, sexual behavior history, microorganisms found in the mouth, and immune response. The study will also explore whether people who test positive for a HPV protein (HPV16 E6) are more likely to develop oral cancer and evaluate how cell counts (HIV and CD4) affect the persistence of oral HPV for study participants who have participated in previous studies called “MACS” or “WIHS”.
Link to study: Men and Women Offering Understanding of Throat HPV - Full Text View - ClinicalTrials.gov
The Sinai Robotic Surgery Trial in HPV Positive Oropharyngeal Squamous Cell Carcinoma (SCCA) (SIRS TRIAL)
GCO# 13-1662
STUDY- 13-00597
Principle Investigator: Raymond Chai, MD
Study Manager: Alecia Charles, MPH
Study Summary: Generally, patients with Human Papilloma Virus Positive Oropharyngeal Squamous Cell Carcinoma (HPVOPC) are curable, young and will live for prolonged periods. They are at high risk for long-term toxicity and mortality from therapy. While the long-term consequences of chemotherapy and surgery for head and neck cancer are relatively constrained, high-dose radiotherapy (RT) and chemoradiotherapy (CRT) substantially impact on local tissues and organ function and result in a significant rate of late mortality and morbidity in patients. Studies are now being designed to reduce the impact of RT and CRT for patients.
In this study, patients with intermediate stage HPV positive oropharyngeal cancer will be screened for poor prognostic features and undergo robotic surgery. Patients in whom pathology demonstrates good prognosis features will then be followed without postoperative radiotherapy. Patients with subsequent recurrence will be treated with either surgery and postoperative radiotherapy or postoperative chemoradiotherapy alone. Patients with poor prognostic features (ECS, LVI, PNI) will receive reduced dose radiotherapy or chemoradiotherapy based on pathology. It is expected that over 50% of patients treated with surgery will have had a curative treatment and will avoid radiation therapy entirely and long-term survival will not be changed by withholding radiation therapy to good prognosis patients after surgery. Exploratory biomarkers of risk of recurrence will be collected and studied as part of this trial.
Link to study: https://clinicaltrials.gov/ct2/show/results/NCT02072148?view=results
Rhinology
Observational Study to Assess Changes in Patient Reported Outcomes Associated with XHANCE® Treatment in Patients with Sinonasal Disease in a Real-World Treatment Setting (XHANCE® Observational Study)
GCO#: 21-0415
STUDY: 21-00089
Study Summary: Chronic Rhinosinusitis (CRS) is characterized by inflammation of the nose and paranasal sinuses and is accompanied by symptoms of nasal blockage/ congestion or rhinorrhea and facial pain/pressure and hyposmia. Patients with CRS have limited medical options for treatment. This multi-center registry study aims to explore the impact of XHANCE® on real-world effectiveness (patient reported outcomes, nasal endoscopy, safety) in a broader patient population who may have been prohibited from participation in prior controlled trials, and is intended to provide a more generalizable representation of the US population with sinonasal disease.
ClariFix Rhinitis Randomized Controlled Trial
GCO#: 20-0515
STUDY: 19-00031
Principle Investigator: Anthony Del Signore, MD
Study Manager: Samantha Udondem, MPH
Study Summary: Rhinitis, the inflammation of the nasal mucosa which may result in nasal congestion, rhinorrhea, sneezing, and nasal itching, affects between 10-30% of adults in the US. Current treatments have low effectiveness with prolonged use. The purpose of this study is to demonstrate the superiority of treatment with the ClariFix cryotherapy device compared with a sham procedure in patients with chronic rhinitis.
Link to study: ClariFix Rhinitis RCT - Full Text View - ClinicalTrials.gov
A 24-Week Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Evaluating the Efficacy and Safety of Intranasal Administration of 186 and 372 μg of OPN-375 Twice a Day (BID) in Subjects with Chronic Rhinosinusitis Without the Presence of Nasal Polyps
GCO#: 21-1135
STUDY: 21-00731
Principle Investigator: Anthony Del Signore, MD
Study Manager: Samantha Udondem, MPH
Study Summary: A clinical development program for OPN-375 (XHANCE) in adults with nasal polyposis has been completed. XHANCE is currently approved for the treatment of nasal polyps in patients 18 years of age or older. The purpose of this research study is to see if OPN-375 (fluticasone propionate), a steroid nasal spray with an OptiNose Exhalation Delivery System (EDS) that delivers drug deep into the nose given at a dose of 186 and 372μg (micrograms) twice a day is safe and effective to treat chronic rhinosinusitis.
Link to study: Study Evaluating the Efficacy and Safety of Intranasal Administration of OPN-375 in Subjects With Chronic Sinusitis Without the Presence of Nasal Polyps - Full Text View - ClinicalTrials.gov
Efficacy and Safety of Tezepelumab in Participants with Severe Chronic Rhinosinusitis with Nasal Polyposis (WAYPOINT)
GCO#: 21-1036
STUDY: 21-00188
Principle Investigator: Alfred Iloreta, MD; Anthony Del Signore, MD
Study Manager: Samantha Udondem, MPH; Alecia Charles, MPH
Study Summary: Chronic rhinosinusitis with nasal polyps (CRSwNP) is a chronic heterogenous inflammatory condition of the nasal and paranasal mucosa with limited treatment options. The purpose of this research study is to learn more about the effect and safety of Tezepelumab when given to patients with severe chronic rhinosinusitis with nasal polyposis and also to better understand the studied disease and associated health problems.
Link to study: Efficacy and Safety of Tezepelumab in Participants With Severe Chronic Rhinosinusitis with Nasal Polyposis - Full Text View - ClinicalTrials.gov
Otology/Neurotology
Single-Sided Deafness and Asymmetric Hearing Loss Post-Approval Study
GCO#: 20-3145
STUDY: 20-01546
Principle Investigator: Maura Cosetti, MD
Study Manager: Samantha Udondem, MPH
Study Summary: Unilateral sensorineural hearing loss, also known as single-sided deafness (SSD), is defined as profound sensorineural hearing loss in one ear, with normal hearing thresholds in the opposite ear. The purpose of this research study is to evaluate the long-term safety and effectiveness of the FDA approved MED-EL Cochlear Implant in adults and children with single-sided deafness and asymmetric hearing loss. Data will be collected in candidates meeting the current FDA-approved indication pre-operatively and for three years following implantation.
Link to study: Single-Sided Deafness and Asymmetric Hearing Loss - Full Text View - ClinicalTrials.gov
A Pre-market, Open-label Feasibility, Prospective, Single-arm Multicenter Investigation of Hearing Performance Using the CI624 in Adults with Low-frequency Residual Hearing
GCO#: 21-0377
STUDY: 20-01920
Principle Investigator: Maura Cosetti, MD
Study Manager: Samantha Udondem, MPH
Study Summary: Several factors may contribute to the optimal performance outcomes of Cochlear Implant technology including surgical approach, patient-related and intra-operative factors. The purpose of the feasibility study is to investigate hearing performance (audiometry and speech perception) using the CI624 in a group of adults with low-frequency residual hearing who meet inclusion criteria and their contributing factors.
Link to study: Hearing Implant Performance in Adults with Low-Frequency Residual Hearing – Full Text View – ClinicalTrials.gov
A Pivotal, Prospective, Multicenter, Randomize Control, Blinded Study Evaluating the Efficacy of a Dexamethasone Eluting Slim Modiolar Electrode (CI632D) in the Reduction of Fibrosis as Compared to a Standard Slim Modiolar Electrode (CI632) in a Newly Implanted Adult Population with Bilateral, Post-linguistic, Moderate to Profound Sensorineural Hearing Loss (CI-DEX)
GCO#: 21-1127
STUDY: 20-01918
Principle Investigator: Maura Cosetti, MD
Study Manager: Samantha Udondem, MPH
Study Summary: The reduction of inflammation and fibrous formation after cochlear implant surgery may result in better hearing performance for recipients. Dexamethasone is a strong anti-inflammatory with prior use to treat inflammation in the cochlea, especially in cochlear implant surgery. The primary purpose of this pivotal evaluation is to show the efficacy of the dexamethasone eluting electrode through reduction in electrode impedances as compared to a standard electrode and the improvement of speech recognition from preoperative baseline. The secondary objectives are to assess the benefit-risk balance of a dexamethasone eluting electrode as similar to a standard electrode by comparison of adverse events and speech outcomes.
Link to study: Cochlear Implant With Dexamethasone Eluting Electrode Array – Full Text View – ClinicalTrials.gov
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of SPI-1005 in Meniere’s Disease and Open Label Extension Study to Evaluate the Chronic Safety of SPI-1005
GCO#: 21-1135
STUDY: 21-00889
Principle Investigator: Enrique Perez, MD
Study Manager: Samantha Udondem, MPH
Study Summary: Meniere’s disease (MD) is defined as a triad of episodic vertigo, hearing loss and tinnitus, with no known etiology or approved FDA treatment options. This study is a randomized, double-blind, placebo-controlled, multi-center clinical trial (RCT) with open-label extension study (OLE), of SPI-1005 (ebselen) in adult subjects with definite Meniere's disease with active symptoms within three months preceding study enrollment. The study will evaluate the safety and efficacy of oral SPI-1005 400 mg BID compared to placebo in 200 adults with MD following 28 days of treatment.
Link to study: SPI-1005 for the Treatment of Meniere's Disease (STOPMD-3)
Vestibular Disorders
Vestibular Rehabilitation Utilizing Virtual Environments to Train Sensory Integration for Postural Control in a Functional Context
GCO#: 19-0593
STUDY: 19-00609
Principle Investigator: Jennifer Kelly, MD
Study Manager: Samantha Udondem, MPH
Study Summary: A significant proportion of adults in the United States are at increased risk for falls due to vestibular and imbalance disorders. These disorders may also have a profound effect on one's independence and participation in activities of daily living. The purpose of this research study is to see if a new virtual reality (VR) study device is better than regular treatment for people with vestibular problems (disease of the inner ear).
Link to study: Virtual Environments for Vestibular Rehabilitation - Full Text View - ClinicalTrials.gov
Sensory Integration of Auditory and Visual Cues in Diverse Contexts Given Age, Vestibular Hypofunction and Hearing Loss
GCO#: 18-2272
STUDY: 20-00922
Principle Investigator: Bryan Hujsak, MD
Study Manager: Samantha Udondem, MPH
Study Summary: Over 1/3 of adults in the United States seek medical attention for vestibular disorders and hearing loss, disorders that can triple one's fall risk and have a profound effect on one's independence and participation in simple activities of daily living. This prospective study will contribute to a better understanding of the auditory contribution to balance in artificial and real-world listening environments and will establish distinct patterns of vestibular disorders with and without hearing loss as compared with typical aging. The results will inform the development of improved behavioral approaches for the rehabilitation of chronic vestibular disorders.
Link to study: Sensory Integration of Auditory and Visual Cues in Diverse Contexts - Full Text View - ClinicalTrials.gov
Observational Studies
Thyroid Cancer
WTC-Related Pollutants in Thyroid Cancer Tissue
GCO#: 20-4001
Study: 20-01877
Principle Investigator: Maaike van Gerwen, MD, PhD
Study Coordinator: Mathilda Alsen, MPH
Study Summary: An excess risk of thyroid cancer has been found among World Trade Center (WTC) first responders who have been exposed to the WTC dust. The objective of this study is to investigate the distribution of WTC-related pollutants in tissue of WTC first responders diagnosed with thyroid cancer.
Thyroid Cancer Aggressiveness in Agent Orange Exposed Veterans
GCO#:20-2283
STUDY: 20-02168
Principle Investigator: Maaike van Gerwen, MD, PhD
Study Coordinator: Mathilda Alsen, MPH
Study Summary: The objective of this study is to investigate whether past exposure to 2,3,7,8-Tetrachlorodibenzo-p-Dioxin (TCDD), commonly known as Agent Orange, is associated with more aggressive thyroid cancer features, including higher rates of metastasis and cancer recurrence or lower survival, as well as more aggressive genetic changes. Results of this study will be directly applicable to improve current management protocols for thyroid cancer patients exposed to TCDD.