An interventional study of Blood collection and Saliva collection in Head and Neck Cancer, sponsored by Medical University of South Carolina. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-30.
Sponsored by Medical University of South Carolina · Not applicable, Interventional, and Basic science
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.
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.
2,403 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.
This study's enrollment of 24 is below the median of 47 across 1,791 interventional studies indexed under Head and Neck Neoplasms.
Browse Head and Neck Neoplasms studies →Medical University of South Carolina is the lead sponsor of 871 studies on the registry; 163 are open to participants now.
Of its 131 completed or terminated interventional studies of FDA-regulated products, 104 (79%) have results posted.
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Exclusion criteria:
Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Other: Blood collection · Other: Saliva collection · Other: Tissue collection · Other: Surveys
Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Other: Blood collection · Other: Saliva collection · Other: Tissue collection · Other: Surveys
Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Other: Blood collection · Other: Saliva collection · Other: Tissue collection · Other: Surveys
Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Other: Blood collection · Other: Saliva collection · Other: Tissue collection · Other: Surveys
Blood, tissue and saliva specimen will be collected. Surveys will be administered.
Other: Blood collection · Other: Saliva collection · Other: Tissue collection · Other: Surveys
30cc of blood will be collected.
5cc of saliva will be collected.
Up to 10mg of tissue will be collected.
The Behavioral Risk Factor Surveillance System (BRFSS), Functional Assessment of Cancer Therapy - Head and Neck module (FACT-HN) the Chicago Priority Scale, Cancer Survivor Unmet Needs surveys will be administered at baseline and 3 months post-surgery.
Count of patients who have research blood, saliva and tissue samples collected.
The number of participants to have research blood, saliva and tissues samples collected.
Time frame: 1 month (at the time of surgery)
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2019 to primary completion in Jul 2021, 29 months.
Of 412 non-industry interventional studies with no phase under Head and Neck Neoplasms, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 67. This study's 29 months is below that.
Counting every sponsor, half of 427 studies reached it within 34 months; a quarter within 18 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
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Medical University of South Carolina →