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NCT04599309 - Real-time Detection of ctDNA and/or HPV DNA in High-risk Locally-advanced Head and Neck Squamous Cell Carcinoma

Official Title
Real-time Detection of ctDNA and/or HPV DNA in High-risk Locally-advanced Head and Neck Squamous Cell Carcinoma (LA-HNSCC): The Pre-MERIDIAN (Molecular Residual Disease Interception in High-risk LA-HNSCC) Study.
Brief Title
Real-time Detection of ctDNA and/or HPV DNA in High-risk Locally-advanced Head and Neck Squamous Cell Carcinoma
Protocol ID
NCT04599309
Lead Sponsor
University Health Network, Toronto
Brief Summary
This research study will include patients with high risk locally advanced head and neck squamous cell carcinoma (LA-HNSCC) of the oral cavity, oropharynx, hypopharynx or larynx and patients that are starting on standard definitive treatment. Patients with both stage III HPV positive and stage III HPV negative will be included. In this study, we aim to evaluate feasibility of ctDNA and/or HPV DNA detection in real time in high-risk LA-HNSCC.
Detailed Description
PRE-MERIDIAN aims to study the kinetics of ctDNA and HPV DNA after standard treatment in high-risk LA-HNSCC patients. This is an important study to understand their role in detecting MRD and determine optimal timing for ctDNA and HPV DNA quantification for future studies in immunotherapy. We hypothesize that HPV DNA (in HPV+) +/- ctDNA detection in plasma after standard therapy may be quantified and monitored as MRD in high risk LA-HNSCC patients. We further hypothesize that detection of MRD in high risk LA-HNSCC after standard therapy may predict recurrence. Finally, we hypothesize that ctDNA time-to-clearance will be longer than 4-6 weeks after the end of treatment in some LA-HNSCC patients and therefore MRD may be further tested at 8-10 weeks after the end of standard therapy
Study Period
-
Enrollment Count
35 participants
Eligibility Criteria
Inclusion Criteria: - Histologically or cytological confirmed LA-HNSCC of the oral cavity, oropharynx, hypopharynx, or larynx. - Stage III HPV Positive or Stage III-IV HPV negative. - Availability of tumor sample - Patients who are candidates for standard definitive treatment defined as: - Surgery followed by radiotherapy +/- chemotherapy OR - Definite radiotherapy OR - Definite chemoradiotherapy. Exclusion Criteria: - Early stage HNSCC (I and II) - Distant metastatic HNSCC
Filters
Cancer
Head and Neck Squamous Cell Carcinoma
Head and Neck Cancer
ACTIVE_NOT_RECRUITING
ADULT
OLDER_ADULT