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

NCT06380686 | Recruiting

• 1 other identifier: AIO-KHT-0322/ass
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Squamous Cell Carcinoma of the Oral Cavity; Squamous Cell Carcinoma of the Oropharynx; Squamous Cell Carcinoma of the Hypopharynx; Squamous Cell Carcinoma of the Larynx

Keywords

SCCHN

Outcome Measures

Primary Outcomes (7)

• Sociodemographic factors

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

  3 years

• Treatments

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

  3 years

• Response rates

  Response rates

  3 years

• Treatment decision

  Physician-reported parameters affecting treatment decision

  3 years

• Progression-free survival

  Progression-free survival

  3 years

• Time-to-treatment-failure

  Time-to-treatment-failure

  3 years

• Overall survival

  Overall survival

  3 years

Interventions

data collection OTHER

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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

Sponsors & Collaborators

• AIO-Studien-gGmbH: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (2)

Universitätsklinikum Essen

Essen, 45147, Germany

NOT YET RECRUITING

Onkologie/Studienzentrum am Raschplatz GbR

Hanover, 30161, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

For future translational research projects, the location of tissue samples in local pathologies will be recorded for patients who have consented to the use of their tissue samples, creating a decentralized biobank. Future translational research projects cannot be pre-defined. Any future translational research project will be described in detail in a project plan and submitted to an ethics committee for review and approval.

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Victor Grünwald, Prof. Dr.

  Universitätsklinikum Essen

  STUDY DIRECTOR

• Michael Pogorzelski, Dr.

  Universitätsklinikum Essen

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Project Manager

CONTACT

+49 (0)30 814534431; kht-register@aio-studien-ggmbh.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Target Duration: 36 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2024
• First Posted: April 24, 2024
• Study Start: November 7, 2024
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2030
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (2)