Head & Neck

 Steven Cannady, M.D.

Head and Neck Outcomes
Clinical Research – open

Patients who have already consented to the Otorhinolaryngology Research Registry will be invited to participate in this sub-protocol involving the administration of functional outcome surveys.

ALTO (Anterolateral Thigh Osteocutaneous) Flap
Chart Review – open

The purpose of this study is to review pre-operative, intraoperative, and post-operative measures and observe their functional outcomes for a population of patients who have undergone reconstruction of complex head and neck defects using a novel osteomyocutaneous variation on the anterolateral thigh free flap at the University of Pennsylvania.

PostOp Reconstruction Outcome Measures
Chart Review – open

This is a chart review of clinical data that is collected during routine clinical care. The objective of this study is to review retrospective pre-operative, intraoperative, and post-operative measures and observe their functional outcomes for a population of patients who have undergone reconstruction of complex head and neck defects utilizing a variety of reconstructive methods.

Free Flap Outcomes after TORS
Chart Review – open

This is a retrospective chart review that aims to describe outcomes of microvascular free flap reconstruction in patients who have undergone TORS resection of advanced oropharyngeal cancer.

Financial Impact of Free Tissue Transfer Reconstruction
Chart Review – preparing to begin

A retrospective review of the financial impact and costs associated with clinical decisions and patient care for patients undergoing head and neck cancer surgery as well as free tissue transfer for reconstruction.

Ara Chalian, M.D.

Modeling Post-Operative Hypocalcemia
Clinical Research – preparing to begin

This study investigates whether physicians can better predict and prevent post-thyroidectomy hypocalcemia using an algorithm including measurement of post-operative PTH levels.

Jason Newman, M.D.

Head and Neck Sarcoma Outcomes
Chart Review – open 

This is a retrospective review of patient charts for demographics and treatment protocols of head and neck sarcomas and their responses to treatment, recurrance rates and survival patterns from 2 institutions (the Hospital of the University of Pennsylvania and the Pennsylvania Hospital) from 1984 to May 2013.

Microbiomes and Mucositis During Radiotherapy
Clinical Research – open 

During head and neck radiotherapy, there are changes in the dental plaque microbiome during the course of treatment. However, changes of the mucosal microbiota associated with treatment-related oropharyngeal mucositis have not been characterized, and provide a potentially novel avenue for therapeutic intervention in head and neck cancer patients. This protocol’s objectives are to determine and characterize the microbial environment and degree of treatment related mucositis of the oropharyngeal mucosa in patients with squamous cell carcinoma (SCC) undergoing multimodality treatment.

Clinical Research – open 

This is a randomized, multi-center, multi-national Phase 2b clinical trial of neoadjuvanty and adjuvant therapy with the IRX-2 regimen, intended for patients with diagnosed Stage III or IVA untreated Squamous Cell Carcinoma (SCC) of the oral cavity who are candidates for resection with curative intent. Subjects will be randomized 2:1 to either Regimen 1 or Regimen 2 and treated for 21 days prior to surgery and then postoperatively with a booster regimen given every 3 months for 1 year (a total of 4 times.)

Cutaneous Squamous Cell Carcinoma Outcomes
Chart Review – open 

This is a retrospective cohort study of evaluating immunocompromised patients who have been treated for cutaneous squamous cell carcinoma in the Penn Dermatology and Otorhinolaryngology Departments.

Culture of Human Taste Progenitors and Papillae
Clinical Research – open 

Leucine-rich repeat-containing G protein-coupled receptor 5 and its homologs have been identified as markers of stem cells in the posterior tongue and, to a lesser degree, multi-potent cells in the anterior tongue.  We plan to use residual human tongue tissue containing circumvallate and fungiform taste papillae to develop a primary cell culture line as well as isolate taste progenitor cells for organoid culture to better understand the mechanisms of taste cell generation and differentiation.

Gene Expression Array to Predict Recurrence of cSCC
Clinical Research – open 

Development and Validation of a Gene Expression Assay to Predict the Risk of Recurrence Disease in Cutaneous Squamous Cell Carcinoma (cSCC). Currently there is no prognostic molecular signature for cSCCs.  The goal of this study is to develop and validate a gene expression assay to predict recurrences of cSCC utilizing nucleic acid amplification and/or sequencing technologies as a stand alone test or in combination with clinicopathologic factors.

Bert W. O’Malley Jr., M.D.

Head and Neck Tissue and Serum Bank
Clinical Research – open 

The aim of this project is to establish a Head and Neck Tissue bank. The objective of the Bank is to provide research investigators within the departments of Otorhinolaryngology, Pathology and Laboratory Medicine, Dermatopathology, Oral & Maxillofacial Surgery and Oral Medicine with tissue sections from head and neck sites including the pharynx, larynx, sinuses, temporomandibular joints, salivary glands, and thyroid glands.   These tissue samples may include normal, precancerous and cancerous tissue, from patients with cancerous, precancerous and/or inflammatory oral and sinus mucosal disorders; and/or buffy coat, plasma, and/or serum, from blood samples, and/or saliva..  The specimens will be used for tumor marker studies, genetic DNA, RNA, protein, and other studies to elucidate the pathogenesis of various head, neck, sinus, and oral diseases.

Otorhinolaryngology Research Registry
Clinical Research – open 

The objective of this project is the development of a research registry for the Department of Otorhinolaryngology for the purpose of performing retrospective chart review studies, and prospectively screening potentially eligible subjects for future research studies conducted in the Department of Otorhinolaryngology.

Christopher Rassekh, M.D.

Chondrosarcoma and Chondroid Chordoma
Chart Review – open 

This study is designed to evaluate lesions of the skull base, particularly of the clivus and petroclival region which are classified as chondrosarcoma or chondroid chordoma. Patients with histologic diagnoses of these two entities will be identified from the pathology database and evaluated for calcification patterns.

Level I Neck Dissection Outcomes
Chart Review – open

This study is designed to look at the outcome of neck dissection. The first phase of the study is to evaluate patients who have undergone neck dissection with the modified technique of level I dissection. The first phase will involve identifying patients who underwent staged neck dissection following Transoral Robotic Resection. The study involves a review of the medical records to determine the overall complication rate and node status of the neck dissections in these patients.

TORS: Parapharyngeal Outcomes 1
Chart Review – open

Patients who have parapharyngeal space tumors removed via a transoral (Robotic) approach will be compared to those who underwent traditional open approaches: we will review the medical records of patients who underwent surgery for parapharyngeal space tumors for 1) surgical approach 2) pathology 3) radiology 4) surgical findings 5) complications.

REACT: Radiographically Enhanced Airway Clinical Tool
Clinical Research – open

We have designed a tool which includes clinical and radiographic parameters of airway measurement. These will be combined to determine if we can better predict situations when difficult intubation or surgical exposure will create clinical problems. We will obtain these measurements preoperatively in patients who will undergo Transoral Robotic Surgery and correlate them with Cormack and Lehane grade of intubation, percentage of glottic opening (POGO) score and degree of surgical exposure.

Sialoendoscopy Retrospective Review
Chart Review – open

This is a retrospective review of sialoendoscopy patients seen at UPHS since the clinic opened approximately 2 years ago. Patient characteristics, treatment modalities, clinical course, and follow-up will be reviewed and reported in the literature in a non-identifiable manner.

Parapharyngeal Space Outcomes 2
Chart Review – open

This is a retrospective chart review study expanding on findings from a previous protocol (#814981). Patients who had parapharyngeal space tumors removed between Jan. 1, 2004, and March 22, 2016 via a transoral robotic (TORS) approach will be compared to those who had traditional open surgeries and to those who had combined (TORS + open) surgeries in that same time frame. We will focus on: 1) surgical approach 2) pathology 3) radiology 4) surgical findings 5) complications.

Gregory Weinstein, M.D.

Supraglottic Laryngectomy (SGL) Outcomes
Chart Review – open

This is a retrospective review of the oncologic and functional outcomes of patients with laryngeal squamous cell carcinoma treated with supraglottic laryngectomy at the University of Pennsylvania over the last 25 years.

Hypopharyngeal Cancer Outcomes
Clinical Research – open

Hypopharyngeal cancer may be treated with radiation, chemoradiation, surgery or a combination of all these modalities. This is a retrospective review of all patients with hypopharyngeal cancer treated with primary surgery. We focus on patients treated with either an open supracricoid hemilaryngopharyngectomy or treated with robotic surgery, from 1991-2013 treated at the University of Pennsylvania in order to review the surgical approach applied, as well as patient outcomes.

Oncologic & Functional Outcomes of All TORS Patients
Chart Review – open

This is a review of the oncologic and functional outcomes of all patients who has undergone transoral robotic surgery (TORS) at the University of Pennsylavania.

ECOG E3311: TORS Plus IMRT for Resectable p16+ Oropharyngeal Cancer
Clinical Research- open

The incidence of base of tongue and tonsillar carcinomas has been increasing. The main hypothesis of this study is that TORS is feasible and effective in low- to intermediate-risk, HPV+ OPSCC patients. It is hypothesized that this permits pathologic-risk adjusted reduction in adjuvant therapy and radiotherapy treatment planning benefits and may be associated with favorable functional and QOL benefits without negatively impacting oncologic results. Targeted enrollment in 377 people in the U.S.

TORS and HPV16 E6 Antibody Positivity
Clinical Research – open

This study is a single center, cross-sectional trial over the course of 10 years involving approximately 400 subjects. Its objectives is to assess the incidence of HPV16 E6 seropositivity in patients undergoing routine OSA including standard palatine tonsillectomy and TORS lingual tonsillectomy and correlate HPV16E6 seropositivity with pathologic changes in the palatine and lingual tonsillar tissue.

Post-laryngectomy Stomal Stenosis
Chart Review – open

This is a retrospective review of available, in-house data which targets adult patients who have undergone total laryngectomy, developed stomal stenosis, and subsequently undergone cervial tracheoplasty. The study will review pre-operative, intra-operative, post-operatives, and overall outcomes of the target population.

TORS for Carcinoma of Unknown Primary
Chart Review – open

This is a retrospective chart review that aims to describe outcomes of the surgical success rate of identifying carcinoma of unknown primary using TORS approach.

Global Head and Neck TORS
Chart Review – open

Cohort Study of the Oncologic and Functional Outcomes of All Head and Neck Cancer Patients within the Health System of the University of Pennsylvania. The aim of this cohort study is to determine the oncologic and functional outcomes following surgery for head and neck cancer.

Clinical Research – open

A Prospective, Multicenter Investigation of the da Vinci SP Surgical System in TORS Procedures for Resection Malignant Tumors.   The goal of this clinical trial is to provide additional data to confirm safety and performance of the da Vinci SP Surgical System in a human clinical setting. This limited confirmatory study is intended to provide a bridge between the clinical data on the cleared da Vinci Si and the expected clinical performance of the da Vinci SP, and to confirm that da Vinci SP does not raise any new issues of safety or effectiveness.