Transdisciplinary Oral/Oropharyngeal Cancer Research & Care in Head and Neck Cancer (TORCH)



Status:Recruiting
Conditions:Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:January 28, 2019
End Date:December 30, 2020
Contact:Brittanie Weinerman
Email:hcc-clinical-trials@musc.edu
Phone:843-792-9321

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Transdisciplinary Oral/Oropharyngeal Cancer Research & Care in Head and Neck Cancer (TORCH): A Prospective Non-Randomized Study by the Head and Neck Oncology Group (HNOG) at the Medical University of South Carolina (MUSC)

The purpose of this research study is to see if it is possible to collect tissue, saliva and
blood samples from patients who are having surgery and send those samples to different labs
across MUSC. The researchers in these labs will collect tissue, blood and saliva samples
before surgery and during surgery to see if there are any changes in the samples. They will
compare the changes in the samples to the clinical outcomes. Patients will also be given
surveys to evaluate patient preferences, anxiety/distress, symptom severity, support by HPV
status.

The primary objective of this exploratory, proof of concept study is to facilitate
translational science spanning clinicians and basic scientists to obtain tissue samples, PDX
models, and clinical data in order to successfully analyze tissue linked to clinical outcomes
in head and neck cancer, resulting in the methodological and statistical framework for a
larger scale clinical trial in the future. While the incidence of HNSCC has been steadily
decreasing over the last thirty years, the incidence and prevalence of oropharyngeal cancer
squamous cell carcinoma (OPSCC) and young patients with oral tongue cancer has increased in
the face of an overall decline in smoking prevalence. Over the past few years, evidence has
emerged that oropharyngeal cancer is rising in incidence so rapidly that it has been
described as an "epidemic" and that it has or soon will surpass cervical cancer in both
incidence and mortality. In fact, over 30,000 patients will be diagnosed with oropharyngeal
cancer in the US per year, making it the most rapidly rising head and neck cancer in
incidence. Despite this unique etiopathogenesis, treatment and toxicities related to
treatment have not changed. This collaboration and interdisciplinary study will be the first
of its kind to address these important issues of cancer site, HPV status, tobacco history,
gender, age, and race using both patient tissue and PDX models to identify novel and unique
biomarkers. Also, innate to this project is the link between five separate laboratories each
conducting unique biomarker analysis.

Inclusion criteria:

1. Age > 18 years

2. Ability to sign informed consent

3. New diagnosis of stage I-IVa oral cavity squamous cell carcinoma of the tongue or
oropharyngeal squamous cell carcinoma confirmed by pathology report. Patients with
Unknown primary of the neck that is HPV+ are eligible.

4. Planning to undergo surgery as a part of definitive treatment

Exclusion criteria:

1. Squamous cell carcinoma metastasis to node(s) of neck with unknown primary tumor site
that is HPV negative.

2. Already received some treatment, such as chemotherapy, radiation, or surgery for
his/her disease at another institution when presenting to MUSC. An exception is
neoadjuvant PD-1 blockade.

3. History of radiation therapy, for any indication, to the head and neck region

4. History of other cancers (excluding non-melanoma skin cancer)
We found this trial at
1
site
171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Principal Investigator: Terry Day, MD
Phone: 843-792-9321
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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mi
from
Charleston, SC
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