ctDNA as a Biomarker for Treatment Response in HNSCC

Carcinoma, Squamous Cell of Head and Neck Clinical Trial

— PECAN  

Official title:

Prospective Study Evaluating ctDNA as a Biomarker for Treatment Response in Head and Neck Squamous Cell Carcinoma'

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03540563
• Other study ID #: N18PCN
• Status: Completed
• Phase: N/A
• Start date: July 16, 2018
• Est. completion date: August 1, 2023

Study information

• Verified date: January 2024
• Source: The Netherlands Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Tumours continually shed DNA into the circulation, where it can be accessed. This circulating tumour DNA (ctDNA) directly reflects tumour burden and has great potential to be a sensitive biomarker for treatment recurrence. These "liquid biopsies" could give a more real-time picture of the genomic status and evolution of a tumour and can be easily assessed for measurement of different biomarkers. However, in head and neck squamous cell carcinoma (HNSCC) patients treated with primary curative radiotherapy, data regarding ctDNA kinetics and its correlation with outcome are scarce. A new or additional tool for response evaluation next to or instead of conventional imaging after treatment would be beneficial to detect recurrences in an earlier stage, thereby increasing the chances of success of salvage therapy. More importantly, an early response parameter during treatment could help to identify patients that have a good treatment response and might benefit from treatment adaptation. With this study, we aim to reveal ctDNA as an effective tool for future dose (de)-escalation trials in HNSCC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• = 18 years of age

• Stage II-IV carcinoma of the larynx, hypopharynx, oral cavity or HPV negative oropharynx or stage II-III HPV positive oropharyngeal carcinoma, histologically confirmed according to the American Joint Committee on Cancer (AJCC) staging manual 8th edition

• Indication for primary curative radiotherapy with or without concurrent radio sensitizer

• WHO performance status 0-2

• Signed written IC

Exclusion Criteria:

• Metastatic disease

• Radiotherapy with palliative intent

• Diagnosis of any other malignancy within 5 years prior to start of treatment except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix, or low-grade (Gleason 6 or below) prostate cancer on surveillance with no plans for treatment intervention (e.g. surgery, radiation or castration).

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Carcinoma, Squamous Cell of Head and Neck
• Squamous Cell Carcinoma of Head and Neck

Intervention

Other:
• Blood draw
Blood will be drawn to assess ctDNA

Locations

Country	Name	City	State
Netherlands	Antoni van Leeuwenhoek	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The number of patients in which ctDNA measurement (in amplifiable copies per millilitre blood and saliva) accurately predicts treatment outcome within 2 years after treatment, in terms of FFP.	ctDNA biomarker	2 years
Secondary	CtDNA kinetics (clearance time, drop below a certain level, complete absence, etc.) during radiotherapy as a predictor for disease recurrence within 2 years after treatment, in terms of FFP.	ctDNA biomarker	2 years
Secondary	Levels of ctDNA at the time of corresponding conventional imaging in relation to disease occurrence.	ctDNA biomarker	3 years
Secondary	The number of traceable mutations found in blood / saliva in comparison with mutations found in tissue biopsies.	ctDNA biomarker	3 years
Secondary	The tumours' genomic status and epigenetic evolution over time under pressure of radiotherapy, in terms of number of different detectable mutations at all specified time points.	ctDNA biomarker	3 years
Secondary	Levels of ctDNA in blood compared to saliva at the same time points.	ctDNA biomarker	At study completion, after 3 years
Secondary	Levels of ctDNA before treatment compared to other clinical/biological parameters in the prediction of treatment response.	ctDNA biomarker	3 years