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Biomarker Analysis for Head and Neck Cancer

N/A

Waitlist Available

Led By Besim Ogretmen, PhD

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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.

Planning to undergo surgery as a part of definitive treatment

Must not have

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

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 month (at the time of surgery)

Awards & highlights

No Placebo-Only Group

Summary

This trial is looking at whether changes in tissue, blood, and saliva samples can be linked to different clinical outcomes in patients.

Who is the study for?

The TORCH study is for adults over 18 with newly diagnosed or recurrent oral cavity or oropharyngeal cancer, who are planning surgery as part of their treatment. It includes those with HPV+ unknown primary neck cancers but excludes individuals previously treated for these conditions elsewhere, those with HPV- metastasis to the neck, and anyone who's had radiation therapy to the head and neck.

What is being tested?

This research aims to collect tissue, saliva, and blood samples from patients undergoing surgery for head and neck cancers. The goal is to analyze changes in these samples before and during surgery and relate them to patient outcomes. Participants will also complete surveys on personal preferences, anxiety levels, symptom severity, and support related to HPV status.

What are the potential side effects?

Since this trial involves sample collection rather than drug testing, there are no direct side effects like you'd expect from medication. However, participants may experience discomfort or minor risks associated with blood draws or biopsies typically done during surgical procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been diagnosed with a specific type of throat or tongue cancer, or I have HPV+ cancer in my neck with an unknown primary source.

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I am scheduled for surgery as part of my main cancer treatment.

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I am older than 18 years.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had radiation therapy to my head or neck.

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My cancer has spread to neck nodes, is squamous cell type, and is not caused by HPV.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 month (at the time of surgery)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 month (at the time of surgery)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month (at the time of surgery) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Count of patients who have research blood, saliva and tissue samples collected.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.