Head and Neck Carcinoma Clinical Research Platform for Molecular and Blood-based Biomarkers, Treatment and Outcome

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAIO-Studien-gGmbH

About this trial

Prospective, open, non-interventional, multi-center clinical registry study with the aim to establish a comprehensive research platform reflecting the real-world treatment landscape for recurrent/metastatic head and neck tumor patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

None

Trial population

Adult patients with histologically or cytologically confirmed malignancy of the head neck area including but not limited to * squamous cell carcinoma (SCC) of the oral cavity, oropharynx, hypopharynx or larynx * not amenable for curative treatment who receive palliative systemic treatment or best supportive care.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • data collection

    Other intervention

    Demography, Social history, Riskfactors, Relevant medical history, Oncological family history, Disease \& treatment history, Molecular Pathology and Results, Treatment data, Response data, progession free survial, overall survival.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Sociodemographic factors

Highest level of education, Employment status, Current professional activity, Professional risk factors, Level of self-sufficiency, Care degree

Time frame
3 years
2

Treatments

Types of local therapies (surgery, radiotherapy, radiochemotherapy), systemic therapy and therapeutic sequences

Time frame
3 years
3

Response rates

Response rates

Time frame
3 years
4

Treatment decision

Physician-reported parameters affecting treatment decision

Time frame
3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

AIO-Studien-gGmbH

Lead sponsor

Merck Sharp & Dohme LLC

Collaborator