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Completed

NCT Number: NCT03540563

ctDNA as a Biomarker for Treatment Response in HNSCC

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Antoni van Leeuwenhoek

Amsterdam, 1066CX, Netherlands

Who can participate

Healthy volunteers accepted: No

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

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).

Treatment and study plan

Blood Draw

Other

Blood will be drawn to assess ctDNA

Primary outcomes

  1. 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.

    Time frame: 2 years

    ctDNA biomarker

Secondary outcomes

  1. 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.

    Time frame: 2 years

    ctDNA biomarker

  2. Levels of ctDNA at the time of corresponding conventional imaging in relation to disease occurrence.

    Time frame: 3 years

    ctDNA biomarker

  3. The number of traceable mutations found in blood / saliva in comparison with mutations found in tissue biopsies.

    Time frame: 3 years

    ctDNA biomarker

  4. 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.

    Time frame: 3 years

    ctDNA biomarker

  5. Levels of ctDNA in blood compared to saliva at the same time points.

    Time frame: At study completion, after 3 years

    ctDNA biomarker

  6. Levels of ctDNA before treatment compared to other clinical/biological parameters in the prediction of treatment response.

    Time frame: 3 years

    ctDNA biomarker

Sponsors and collaborators

Lead sponsor

The Netherlands Cancer Institute

Other

Registry information

Official study title

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

Acronym: PECAN

Important dates

Study start
2018
Primary completion
2023
Study completion
2023
First posted
May 30, 2018
Registry last updated
Feb 1, 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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