Head and Neck Cancer Trial, Recruiting NCT04099290 Sponsor: UNC Lineberger Comprehensive Cancer Center Condition: Head and Neck Cancer
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Head and Neck Cancer Trial, Recruiting

NCT04099290
Recruiting Not Applicable

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You must be willing to sign a consent form agreeing to take part in the study and allowing your personal health information to be used
  • You must agree to allow researchers to use leftover tissue from your biopsy or surgery, and to have blood samples taken at regular intervals
  • You must be 18 years old or older when you sign the consent form
  • You must have a newly diagnosed, lab-confirmed squamous cell cancer of the head and neck, specifically in the mouth (oral cavity), throat (oropharynx), or voice box (larynx)
  • You must be planning to have surgery to fully remove the main tumor at UNC-Chapel Hill hospital, with the goal of curing the cancer
  • Your cancer must not have been treated before, and must be at a certain stage — either a larger tumor (T3 or T4), or a smaller tumor (T1 or T2) that has spread to nearby lymph nodes, but not to distant parts of the body
  • You must be willing and able to receive follow-up treatment after surgery, such as radiation therapy with or without other treatments, either as standard care or as part of another clinical trial
  • Tumor tissue from your diagnosis must be available for research testing
  • You must be able and willing to follow the study procedures, as judged by the study team

Who may not be able to join:

  • You cannot join if there is evidence that your cancer has spread to distant parts of the body
  • Women who are pregnant or currently breastfeeding cannot join
  • You cannot join if you have had another type of cancer in the past 5 years (though a history of certain early-stage or minor skin cancers may still allow you to be eligible — confirm with trial site)
  • People whose head and neck cancer started in the skin, such as basal cell or squamous cell skin cancer, cannot join
  • You cannot join if you have already received chemotherapy, immunotherapy, biological therapy, or hormonal therapy to treat this head and neck cancer (however, hormonal therapy taken for unrelated reasons, such as hormone replacement therapy, is acceptable)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

Contact this trial

Principal Investigator: Siddharth Sheth, MD, UNC Health Care

Phone: (919) 966-3856

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Not Applicable
Sponsor
UNC Lineberger Comprehensive Cancer Center
Registry
ClinicalTrials.gov
Start date
14 January 2020
Est. completion
1 February 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Rate of tumor-specific mutation in pre-operative circulating tumor DNA of patients with locally-advanced HNSCC who are receiving surgery for treatment of their primary tumor

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov