Kevin Contrera
This study is being done to determine whether an assay called LymphDetect™ Head and Neck is a useful tool to help guide treatment decisions for patients with head and neck cancer. The LymphDetect™ assay works to detect a certain kind of DNA that is released by tumors called circulating tumor DNA or ctDNA for short. In this study, the presence of ctDNA will be assessed in fluid collected from the surgical drain that will be placed during curative-intent surgical procedure performed as a part of patient standard care. Treatment after surgery is determined by a patient's disease risk category (low-risk, intermediate-risk, or high-risk). Having intermediate-risk with detection of ctDNA in the surgical drain fluid (SDF+) may mean that a patient is at greater risk of their cancer coming back. To reduce this risk, treatment will be more intensive than if ctDNA in the surgical drain fluid (SDF-) was not found.
Patients who are Surgical Drain Fluid (SDF) positive have a more than eight-fold higher risk of Head and Neck Squamous Cell Carcinoma disease recurrence. Whether these pathologically intermediate-risk patients benefit from the addition of concurrent cisplatin to adjuvant radiotherapy is unknown. Various prognostic biomarkers have been proposed to identify patients at high risk of recurrence. Tissue-based biomarkers may be less prognostic after successful tumor extirpation. Several plasma-based ctDNA assays measuring treatment response in HPV- HNSCC are under investigation. However, data is lim…
Inclusion Criteria: 1. Must have histologically or cytologically confirmed newly diagnosed mucosal HNSCC (i.e., oral cavity, oropharynx, hypopharynx, or larynx). o Patients with intermediate-risk disease (stage cT2N0 with adverse pathologic features OR stage cT3-4Nany OR stage cTanyN1-3a) will be preferentially enrolled. 2. Must have received no prior therapies for current malignancy, except for neoadjuvant pembrolizumab. 3. Must be able to undergo curative-intent surgical resection with neck dissection and placement of a drain. 4. Patient is considered a candidate for adjuvant chemothera…
An alkylating agent that contains platinum, which binds to DNA in cancer cells, causing cross-links that prevent DNA replication and repair, leading to cell death, particularly in rapidly dividing cancer cells.
Advanced type of radiation therapy that uses powerful energy beams to kill cancer cells. The energy can come from X-rays, protons or other sources, in which the beams of radiation are carefully customized.
Humanized monoclonal antibody and a PD-1 inhibitor used in cancer immunotherapy that differs from chemotherapy as it does not directly kill cancer cells but stimulates the immune system, particularly T-cells, to recognize and attack cancer cells more effectively.
A tumor-informed ctDNA assay that uses Surgical Drain Fluid (SDF) collected 24 hours after the end of surgery to direct therapeutic intervention.
Performed within 28 days after baseline assessment to remove Head and Neck Cancer tumor(s).
Arctuva estimate
Actual pay is set by the research site.
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