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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month (at the time of surgery)
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Count of patients who have research blood, saliva and tissue samples collected.

Trial Design

5Treatment groups
Experimental Treatment
Group I: Young (<40 years old), Oral Cavity (Tongue) patientsExperimental Treatment4 Interventions
Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Group II: Newly diagnosed, African American/Black, HPV negative, SmokingExperimental Treatment4 Interventions
Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Group III: Neoadjuvant PD-1 Blockade patientsExperimental Treatment4 Interventions
Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Group IV: Caucasian, HPV positive, Smoking patientsExperimental Treatment4 Interventions
Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Group V: Caucasian, HPV positive, Non Smoking patientsExperimental Treatment4 Interventions
Blood, tissue and saliva specimen will be collected. Surveys will be administered.

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor
932 Previous Clinical Trials
7,394,236 Total Patients Enrolled
Besim Ogretmen, PhDPrincipal InvestigatorMedical University of South Carolina
Terry Day, MDPrincipal InvestigatorMedical University of South Carolina

Media Library

Tissue collection Clinical Trial Eligibility Overview. Trial Name: NCT03735745 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is it possible for new participants to join this research endeavor?

"The details posted on clinicaltrials.gov signify that this trial is not taking new applicants at present time, despite being initially listed on January 28th 2019 and amended most recently in August 9th 2022. Nonetheless, there are 548 other medical studies actively looking for patients to enroll."

Answered by AI
~4 spots leftby Apr 2025