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NCT Number: NCT06215612

ctDNA and MRI Parameters in Head and Neck Cancer

Patients undergoing primary radiochhemotherapy for locally advanced head and neck squamous cell carcinomas are included in this study. In addition to standard of care treatment patients will undergo addiational blood draws and MR imaging studies. Circulating cell free tumor DNA will be analysed in the blood samples. BIological data, imaging data and clinical data (such as patient and tumor characteristics, oncologic outcome, side effects) will be analysed in a biomathematical modelling approach.

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Key information

Conditions

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

Age range

19 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Squamous cell carcinoma head and neck
  • Planned primary platinum based radiochemotherapy
  • ECOG 0-2

Exclusion criteria

  • Palliative therapy intent
  • Not MR eligible

Treatment and study plan

Blood draw, MRI

Other

Blood draw, MRI

Primary outcomes

  1. percentage of patients with 50% decrease in ctDNA

    Time frame: 7 weeks after start of radiotherapy

Secondary outcomes

  1. Completion of all planned MR imagings and blood tests

    Time frame: through study completion, an average of 7 weeks

  2. Decrease of tumor volume

    Time frame: 7 weeks after start of radiotherapy

Study contacts

Contact information is provided by the study sponsor or research team.

Franziska Eckert, M.D.

CONTACT

[email protected]

+43-1-40400-26920

Sponsors and collaborators

Lead sponsor

Franziska Eckert

Other

Registry information

Official study title

ctDNA and MR Imaging Parameters as Possible Biomarkers in Primary Radiochemotherapy of Head and Neck Squamous Cell Carcinomas

Important dates

Study start
2024
Primary completion
2027
Study completion
2030
First posted
Jan 22, 2024
Registry last updated
Jan 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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