Actively Recruiting
Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome
Led by AIO-Studien-gGmbH · Updated on 2024-11-13
120
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
A
AIO-Studien-gGmbH
Lead Sponsor
M
Merck Sharp & Dohme LLC
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to create a detailed clinical registry platform to reflect real-world treatment patterns for patients with recurrent or metastatic head and neck tumors, including squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, and larynx. The study seeks to understand molecular and blood-based biomarkers and treatment outcomes to improve therapy strategies in this patient population where new treatments like checkpoint inhibitors have changed care approaches. Participants will be observed without intervention, with data collected on demographics, social history, risk factors, medical and family history, disease and treatment course, molecular pathology results, treatment details, response rates, progression-free survival, and overall survival. The study is designed to be flexible and modular, enabling integration of new research questions and assessments, such as molecular testing, over time to keep pace with evolving treatment standards. During participation, patients' clinical data will be continuously gathered and analyzed over a period of three years, focusing on sociodemographic factors, treatment decisions, response rates, progression, and survival outcomes. This observational study involves patients receiving palliative systemic treatment or best supportive care and aims to provide insights into treatment sequences and outcomes in real-world settings, including rare tumor types. The total follow-up duration for outcome assessment is three years.
CONDITIONS
Brief Title
Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- 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 suitable for curative treatment receiving palliative systemic treatment or best supportive care
- Informed consent provided within four weeks after starting first-line palliative systemic treatment or within six weeks after diagnosis/recurrence for best supportive care patients
You will not qualify if you...
- None
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants are observed over time with collection of clinical and molecular data related to their head and neck carcinoma and treatments received.
Visits scheduled according to routine clinical care over 3 years
Trial Site Locations
Total: 2 locations
1
Universitätsklinikum Essen
Essen, Germany, 45147
Not Yet Recruiting
2
Onkologie/Studienzentrum am Raschplatz GbR
Hanover, Germany, 30161
Actively Recruiting
Research Team
P
Project Manager
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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