Clinical Trials

Inclusion Critieria: 

• Cohorts 1 and 2: Head and Neck Cancers:
  • 18 years or older;
  • Currently diagnosed with a head and neck squamous cell cancer.  Oropharyngeal cancer patients should be p16 and HPV DNA or RNA negative, but testing can be completed following surgical management.  For non-oropharyngeal sites, HPV testing is per provider recommendation (not required);
  • Scheduled or will be scheduled for primary surgical resection with curative intent, with use of post-surgical drain;
  • The participant is cognitively able to consent to participate in the study;
  • The participant is healthy enough for blood draws and sample collection (at the discretion of the Investigator).
• COHORTS 3 and 4: Healthy Controls/Comparators:
  • 18 years or older;
  • The participant is cognitively able to consent to participate in the study;
  • The participant is healthy enough for a blood draw and sample collection (at the discretion of the Investigator);
  • The patient has no history of a cancer diagnosis;
  • Is scheduled to undergo a non-malignancy related surgical procedure, , which result in the use of surgical drain placements similar to those in cohorts 1 and 2.

Exclusion Criteria: 

• COHORTS 1 and 2: Head and Neck Cancers:
  • Subject deemed not fit to participate at the Investigator’s discretion;
  • Participant has a history of a previous cancer diagnosis within the last 5 years, other than: non-melanomatous localized cutaneous malignancies (e.g. SCC, BCC); non-metastatic prostate cancer; and non-metastatic well differentiated thyroid cancers.
• COHORTS 3 and 4: Healthy Controls/Comparators:
  • Subject deemed not fit to participate at the Investigator’s discretion;
  • Participant undergoing surgery for infectious etiology.

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 10/31/23. Questions regarding updates should be directed to the study team contact.