Platform for studying biomarkers and treatments in head and neck cancer
Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based
This study is trying to gather information on how well different treatments work for people with advanced head and neck cancer to help improve future care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | AIO-Studien-gGmbH Academic / other |
| Drugs / interventions | cetuximab, nivolumab, pembrolizumab, chemotherapy |
| Locations | 2 sites (Essen and 1 other locations) |
| Trial ID | NCT06380686 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a comprehensive clinical registry that reflects the real-world treatment landscape for patients with recurrent or metastatic squamous cell carcinoma of the head and neck. It focuses on collecting data related to tumor biomarkers and treatment outcomes, particularly in light of recent advancements such as immune checkpoint inhibitors. The study will link molecular testing results to core data to optimize treatment strategies and provide insights into the management of rare tumor entities. The flexible design allows for the integration of contemporary research questions as they arise.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically confirmed squamous cell carcinoma of the head and neck who are not eligible for curative treatment.
Not a fit: Patients with curable head and neck cancers or those not receiving palliative systemic treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies and outcomes for patients with head and neck cancers.
How similar studies have performed: Other studies have shown success with similar approaches in optimizing treatment strategies for head and neck cancers, particularly with the integration of biomarker data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Able to understand and willing to sign written informed consent * Histologically or cytologically confirmed squamous cell carcinoma of the head and neck (oral cavity, oropharynx, hypopharynx or larynx) * Patients not amenable for curative treatment who receive palliative systemic treatment or best supportive care * Informed consent no later than four weeks after start of first-line palliative systemic treatment. For patients receiving "best supportive care only": no later than six weeks after diagnosis/recurrence or metastatic disease Exclusion Criteria: none
Where this trial is running
Essen and 1 other locations
- Universitätsklinikum Essen — Essen, Germany (Not_yet_recruiting)
- Onkologie/Studienzentrum am Raschplatz GbR — Hanover, Germany (Recruiting)
Study contacts
- Principal investigator: Michael Pogorzelski, Dr. — Universitätsklinikum Essen
- Study coordinator: Project Manager
- Email: kht-register@aio-studien-ggmbh.de
- Phone: +49 (0)30 814534431
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.