Prospective study evaluating ctDNA as a biomarker for treatment response in head and neck squamous cell carcinoma*
- Conditions
- Head and neck cancer10027655
- Registration Number
- NL-OMON46578
- Lead Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
• >= 18 years of age
• Stage II-IV carcinoma of the larynx, hypopharynx, oral cavity or HPV negative oropharynx, or stage II-III HPV positive oropharyngeal carcinoma, according to the American Joint Committee on Cancer (AJCC) staging manual 8th edition
• Indication for curative radiotherapy with or without concurrent radiosensitizer
• WHO performance status 0-2
• signed written informed consent
• Metastastic disease
• Radiotherapy with palliative intent
• Diagnosis of any other malignancy within 5 years prior to start of treatment except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix, or low-grade (Gleason 6 or below) prostate cancer on surveillance with no plans for treatment intervention (e.g. surgery, radiation or castration).
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To validate ctDNA after treatment as a predictor for the presence of residual<br /><br>disease and for the early detection of tumour recurrence.</p><br>
- Secondary Outcome Measures
Name Time Method <p>1. The prognostic value of ctDNA during treatment as a biomarker for treatment<br /><br>response.<br /><br>2. Timing and accuracy of ctDNA as a predictor for recurrence in comparison to<br /><br>conventional imaging.<br /><br>3. The correlation of traceable mutations found in blood / saliva in comparison<br /><br>to mutations found in tissue biopsies, as a parameter for tumor heterogeneity.<br /><br>4. The tumours* genomic status and epigenetic evolution over time under<br /><br>pressure of radiotherapy.<br /><br>5. Sensitivity and specificity of ctDNA in blood compared to saliva.<br /><br>6. The correlation between ctDNA before treatment and other clinical/biological<br /><br>parameters in the prediction of disease recurrence.</p><br>
Related Research Topics
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