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

Not Applicable

Active, not recruiting

• Conditions: Head and Neck Cancer
• Interventions: Other: Blood collection; Other: Saliva collection; Other: Tissue collection; Other: Surveys

• Registration Number: NCT03735745
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-11-07
• Study First Submitted QC: 2018-11-07
• Study First Posted: 2018-11-08
• Study Start: 2019-01-28
• Primary Completion: 2023-10-31
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-18
• Last Update Posted: 2024-01-22
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caucasian, HPV positive, Non Smoking patients	Blood collection	Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Caucasian, HPV positive, Non Smoking patients	Saliva collection	Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Young (<40 years old), Oral Cavity (Tongue) patients	Blood collection	Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Young (<40 years old), Oral Cavity (Tongue) patients	Saliva collection	Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Neoadjuvant PD-1 Blockade patients	Saliva collection	Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Caucasian, HPV positive, Smoking patients	Blood collection	Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Newly diagnosed, African American/Black, HPV negative, Smoking	Saliva collection	Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Newly diagnosed, African American/Black, HPV negative, Smoking	Tissue collection	Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Neoadjuvant PD-1 Blockade patients	Tissue collection	Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Caucasian, HPV positive, Non Smoking patients	Tissue collection	Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Caucasian, HPV positive, Smoking patients	Tissue collection	Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Caucasian, HPV positive, Smoking patients	Surveys	Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Caucasian, HPV positive, Non Smoking patients	Surveys	Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Caucasian, HPV positive, Smoking patients	Saliva collection	Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Newly diagnosed, African American/Black, HPV negative, Smoking	Blood collection	Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Newly diagnosed, African American/Black, HPV negative, Smoking	Surveys	Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Neoadjuvant PD-1 Blockade patients	Blood collection	Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Young (<40 years old), Oral Cavity (Tongue) patients	Tissue collection	Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Young (<40 years old), Oral Cavity (Tongue) patients	Surveys	Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Neoadjuvant PD-1 Blockade patients	Surveys	Blood, tissue and saliva specimen will be collected. Surveys will be administered.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States