Real-time Detection of ctDNA and/or HPV DNA in High-risk Locally-advanced Head and Neck Squamous … (NCT04599309) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Real-time Detection of ctDNA and/or HPV DNA in High-risk Locally-advanced Head and Neck Squamous Cell Carcinoma
Canada35 participantsStarted 2020-10-15
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial focuses on detecting ctDNA and HPV DNA in real time during treatment — can you explain what that means for me practically, and whether the results from this monitoring would actually change any decisions about my care while I'm in it?
2Since this trial is listed as 'active, not recruiting,' does that mean there's no chance I could still join, or are there any circumstances where exceptions are made for patients in my situation?
3The trial is described as having no phase, which suggests it may be more of an observational or biomarker study rather than a treatment trial — so would participating in this study mean I'd still be receiving standard treatment for my head and neck cancer at the same time?
4HPV status can vary between head and neck cancers — does my specific tumor type or HPV status make me a particularly relevant candidate for a study focused on detecting HPV DNA alongside ctDNA?
5If the goal of this trial is to test whether ctDNA and HPV DNA can be detected in real time, rather than to test a new treatment, what would you say are my best options right now for actually treating my cancer, and how might standard care compare to any investigational approaches?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of high-risk LA-HNSCC patients with successful detection of ctDNA and/or HPV DNA in real time
Timeframe: Through study completion, up to 2 years