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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.
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