ctDNA and MRI Parameters in Head and Neck Cancer

Not Applicable

Not yet recruiting

• Conditions: Carcinoma, Squamous; Head and Neck Neoplasms

• Registration Number: NCT06215612
• Lead Sponsor: Franziska Eckert

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-12-29
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-10
• Last Update Submitted: 2024-01-10
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-22
• Study Start: 2024-02
• Primary Completion: 2027-02
• Study Completion: 2030-02

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

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

Exclusion Criteria

• Palliative therapy intent
• Not MR eligible

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
percentage of patients with 50% decrease in ctDNA	7 weeks after start of radiotherapy

Secondary Outcome Measures

Name	Time	Method
Completion of all planned MR imagings and blood tests	through study completion, an average of 7 weeks
Decrease of tumor volume	7 weeks after start of radiotherapy