Clinical Trials

Clinical research comes from the discoveries made in basic science laboratories. By taking these investigations and discoveries, researchers and scientists can create new therapies and treatments. Below are the listings of our current clinical trials. If you feel you one of the trials is right for you, we ask you contact the trial representative for further information.

Head & Neck Cancer

Molecular Surveillance for Squamous Cell Carcinoma of the Upper Aerodigestive Tract


Development of a screening test for cancer of the mouth and throat: Cancers of the mouth and throat may go undetected in their earliest and most treatable stages. A new test that analyzes the DNA from cells released when an individual gargles is being developed at Johns Hopkins. Any patient who has already been diagnosed with having Squamous Cell Carcinoma of the mouth or throat is eligible to participate.

For further information contact the study coordinator Zubair Khan, MD. 410-955-3157 or the office of Principal Investigator, Wayne Koch, M.D. 410-955-4906. You may also contact the Head and Neck Cancer Research Division at 410-502-5153

Detection of Genetic Alteration in Head and Neck Tumors

The basic genetic steps that lead to a variety of types of head and neck tumors (benign or malignant), including thyroid cancer, salivary gland cancer, squamous cell cancers, and other are currently under active investigation to identify new genetic alterations that can identify cells as cancerous or normal. Identification of these alterations will lead to the development of new, molecularly based therapies. Any patient with a head and neck tumor, either benign or malignant, is eligible for this study.

For further information contact the study coordinator Zubair Khan, MD. 410-955-3157 or the office of Principal Investigator, Wayne Koch, M.D. 410-955-4906. You may also contact the Head and Neck Cancer Research Division at 410-502-5153

Detection of Precancerous and Cancerous Lesions of the Oropharynx with the OpCDx Computer Assisted Analysis of Brush Biopsy Specimens : A Multicenter Prospective Clinical Trial

Cancers of the mouth and throat are most easily treated when caught at their earliest stages. A multicenter clinical trial of OralCDx, a computer assisted method of analysis of oral brush biopsy has already been shown to be highly accurate in detecting oral precancerous and cancerous lesions. A new multicenter clinical trial using the same technology for detection of precancerous and cancerous lesions of the oropharynx is underway at Johns Hopkins. If your doctor has observed a suspicious sore in your throat, you may be eligible to participate. Any patient with a suspicious or non suspicious oropharyngeal lesion (detected by direct or indirect pharyngoscopy) is eligible to be enrolled.

For further information contact the study coordinator Zubair Khan, MD. 410-955-3157 or the office of Principal Investigator, Wayne Koch, M.D. 410-955-4906. You may also contact the Head and Neck Cancer Research Division at 410-502-5153

EndoCDx: Evaluation of pharyngeal and laryngeal lesions with computer-assisted analysis of brush biopsy specimens:

The purpose of this study is to determine the effectiveness of a new test that consists of using a brush to collect cells of a suspicious lesion to detect precancerous and cancerous cells. The new technique will allow doctors to collect cells from the pharynx and larynx to look for cells that may be abnormal. This technique has already been used in other body areas, such as in the mouth, evaluating precancerous and cancerous lesions and has been shown to be very accurate.

Wayne Koch, M.D., Principal Investigator: 410-955-4906; Research Coordinator: Cheryl Conrad 410-955-3155.

Predictors of Diagnostic Delay and Stage of Diagnosis:

The purpose of the study is to determine the extent to which delay of diagnoses predicts stage at diagnosis among persons with head and neck tumors ( benign or malignant ) and to identify the reasons for delay of diagnosis. The long-term goal is to provide data for developing and targeting ways to increase the number of head and neck cancer diagnosed at early stages which may improve outcomes, including survival. Participants will recieve garage parking coupon for completion of questionnaire.

Wayne Koch, M.D., Principal Investigator; Britt Reid, DDS, Co-investigator; Research Coordinator: Cheryl Conrad at 410-955-3155

Psychosocial (non-physical) factors predicting successful use of tracheoesophageal prosthesis.

The purpose of this study is to explore which factors, such as employment and activities, affect a person’s need and pattern of verbal communication. These factors may impact the degree and pattern of use of voice through tracheoesophageal prosthesis (TEP) after laryngectomy.

Wayne Koch, M.D.; Principal Investigator. Contact persons: Robin Samlan, MS; speech/language pathologist at 410-955-1175; Research Coordinator: Cheryl Conrad at 410-955-3155.

Detection of Genetic Alterations and Expression Profile of Premalignant Lesions of the Upper Aerodigestive Tract

A study is currently underway to investigate and look at the mistakes in DNA and genes from "normal cells" and cells from which are suspicious for being cancerous (precancerous lesions) to help us better understand how cancer develops. Specifically, we will look at cells from your mouth and throat to see which genes might be turned "on" or "off" in both suspicious and normal cells. Anybody with a lesion suspicious for cancer (precancerous) and who is undergoing a biopsy of the suspicious area is eligible to be enrolled in the study. Participation does not change the normal treatment plans for patients.
For further information contact the study coordinator Zubair Khan, MD. 410-955-3157 or the office of Principal Investigator, Joseph Califano, M.D. 410-955-6420 You may also contact the Head and Neck Cancer Research Division at 410-502-5153

Molecular Screening in a Population at Risk for Head and Neck Cancer

A study is currently underway to investigate and look at changes in DNA and genes from normal cells in the saliva and blood samples. Specifically, this research study will look at cells from the mouth and/or throat and blood to see which genes are turned "on" or "off". The information from this study will help better understand how often these changes occur in the general population and in people at risk for developing head and neck cancer, which in turn will help to better understand how cancer develops. Any adult who does not currently have head and neck cancer is eligible to be enrolled. Participation is limited to the day of testing and yearly follow ups through phone calls.

Participants will receive a free head and neck examination on the day of testing and may also return for free yearly head and neck exams. Participants will also be compensated in the amount of $20.

For further information contact the study coordinator Zubair Khan, MD. 410-955-3157 or the office of Principal Investigator, Joseph Califano, M.D. 410-955-6420 You may also contact the Head and Neck Cancer Research Division at 410-502-5153

Detection of Novel Mutations and Aberrant Methylation Patterns in Thyroid Tumors

A collaborative study is underway to investigate and look different types of thyroid cancers. Different types of thyroid cancers act in different manners, some are slow growing, do not spread and are completely curable, while others are aggressive, rapid growing and do not respond to current treatments methods. This research is being done to understand why different types of thyroid cancers act differently and will be done done by looking at the genetic mutations that take place in thyroid tumors. This knowledge may one day help doctors predict which thyroid tumors need more aggressive treatment, and may even help to find out how to make tumors less aggressive and easier to treat. Anybody with a thyroid tumor, both cancerous and non cancerous are eligible to be enrolled.

For further information contact the study coordinator Zubair Khan, MD. 410-955-3157 or the offices of Ralph Tufano, M.D. 410-955-6420 or Paul Ladenson, M.D., 410-955-3663. You may also contact the Head and Neck Cancer Research Division at 410-502-5153

Human Papilloma Virus as an Etiology of a Subset of Head and Neck Cancers. Does the Human Papillomavirus cause some cancers of the mouth and throat?

Recent evidence from Hopkins and other institutions indicates that HPV may contribute to the development of these cancers over 1/4th of the time.
Any patient with a Squamous Cell cancer of the mouth and throat is eligible to participate in this study that examines the tumor for evidence of the virus, and collects information about other risk factors that may play a role.

For further information contact the Office of the Principal Investigator, Maura Gillison, M.D, Phd, at 410-502-7412. You may also contact the Head and Neck Cancer Research Division at 410-502-5153

Integrated PET/CT in the Diagnosis and Follow-Up of Head and Neck Cancer Patients:

The diagnosis and follow-up treatment of head and neck cancer is traditionally based on a clinical evaluation and imaging such as a CT with contrast. This study will evaluate the usefulness of positive emission tomography (PET/CT) compared with contrast enhanced CT alone in the decision-making treatment of head and neck cancers.

A PET/CT may provide more accurate staging in head and neck cancer and be a useful tool in evaluations.

For further information, please contact the research program coordinator Cheryl Conrad at 410-955-3155 or the Principal Investigator Ralph Tufano, M.D. at 410-955-3628.