Early detection of head and neck cancer relapse by expression profiling of blood platelets and ctDNA detection in plasma and oral rinses

• Conditions: Head and neck squamous cell carcinomas

• Registration Number: NL-OMON29189
• Lead Sponsor: not applicable

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

•HNSCC stage II, III and IV
•Sufficient knowledge of the Dutch language to understand the aim of the study and the procedures as described in the patient information.
•Signed the informed consent for the study.
•(+)18 years of age

Exclusion Criteria

•Patients scheduled for palliative treatment will be excluded from participation in this study.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Accuracy of early detection of recurrent/metastatic disease in HNSCC patients treated for cure, and the presence of ctDNA in plasma and oral rinses as well as TEPs. In addition, the median and range of time intervals between liquid biopsy findings and relapse will be determined.

Secondary Outcome Measures

Name	Time	Method
-The presence of ctDNA in post-surgical wound rinses as risk factor for relapse<br>-Association of mutations in ctDNA with primary tumor and relapse<br>- Intratumor genetic heterogeneity between biopsies of primary tumor and relapse <br>