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

January 29, 2025 updated by: Medical University of South Carolina

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion criteria:

  1. Age > 18 years
  2. Ability to sign informed consent
  3. Newly diagnosed or recurrent oral cavity squamous cell carcinoma of the tongue (stage I-IVa) 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Caucasian, HPV positive, Non Smoking patients
Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Other: Blood collection
30cc of blood will be collected.
Other: Saliva collection
5cc of saliva will be collected.
Other: Tissue collection
Up to 10mg of tissue will be collected.
Other: Surveys
The Behavioral Risk Factor Surveillance System (BRFSS), Functional Assessment of Cancer Therapy - Head and Neck module (FACT-HN) the Chicago Priority Scale, Cancer Survivor Unmet Needs surveys will be administered at baseline and 3 months post-surgery.
Experimental: Caucasian, HPV positive, Smoking patients
Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Other: Blood collection
30cc of blood will be collected.
Other: Saliva collection
5cc of saliva will be collected.
Other: Tissue collection
Up to 10mg of tissue will be collected.
Other: Surveys
The Behavioral Risk Factor Surveillance System (BRFSS), Functional Assessment of Cancer Therapy - Head and Neck module (FACT-HN) the Chicago Priority Scale, Cancer Survivor Unmet Needs surveys will be administered at baseline and 3 months post-surgery.
Experimental: Newly diagnosed, African American/Black, HPV negative, Smoking
Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Other: Blood collection
30cc of blood will be collected.
Other: Saliva collection
5cc of saliva will be collected.
Other: Tissue collection
Up to 10mg of tissue will be collected.
Other: Surveys
The Behavioral Risk Factor Surveillance System (BRFSS), Functional Assessment of Cancer Therapy - Head and Neck module (FACT-HN) the Chicago Priority Scale, Cancer Survivor Unmet Needs surveys will be administered at baseline and 3 months post-surgery.
Experimental: Young (<40 years old), Oral Cavity (Tongue) patients
Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Other: Blood collection
30cc of blood will be collected.
Other: Saliva collection
5cc of saliva will be collected.
Other: Tissue collection
Up to 10mg of tissue will be collected.
Other: Surveys
The Behavioral Risk Factor Surveillance System (BRFSS), Functional Assessment of Cancer Therapy - Head and Neck module (FACT-HN) the Chicago Priority Scale, Cancer Survivor Unmet Needs surveys will be administered at baseline and 3 months post-surgery.
Experimental: Neoadjuvant PD-1 Blockade patients
Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Other: Blood collection
30cc of blood will be collected.
Other: Saliva collection
5cc of saliva will be collected.
Other: Tissue collection
Up to 10mg of tissue will be collected.
Other: Surveys
The Behavioral Risk Factor Surveillance System (BRFSS), Functional Assessment of Cancer Therapy - Head and Neck module (FACT-HN) the Chicago Priority Scale, Cancer Survivor Unmet Needs surveys will be administered at baseline and 3 months post-surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Count of patients who have research blood, saliva and tissue samples collected.
Time Frame: 1 month (at the time of surgery)
The number of participants to have research blood, saliva and tissues samples collected.
1 month (at the time of surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of South Carolina

Investigators

  • Principal Investigator: Besim Ogretmen, PhD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 28, 2019

Primary Completion (Actual)

July 15, 2021

Study Completion (Actual)

July 15, 2022

Study Registration Dates

First Submitted

November 7, 2018

First Submitted That Met QC Criteria

November 7, 2018

First Posted (Actual)

November 8, 2018

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 29, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 102812

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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