Prospective study evaluating ctDNA as a biomarker for treatment response in head and neck squamous cell carcinoma*

Prospective study evaluating ctDNA as a biomarker for treatment response in head and neck squamous cell carcinoma* - PECAN

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON46578

Enrollment

Registered

2018-04-12

Start date

2018-08-14

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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, according to the American Joint Committee on Cancer (AJCC) staging manual 8th edition • Indication for curative radiotherapy with or without concurrent radiosensitizer • WHO performance status 0-2 • signed written informed consent

Exclusion criteria

Exclusion criteria: • Metastastic 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).

Design outcomes

Primary

Measure	Time frame
To validate ctDNA after treatment as a predictor for the presence of residual disease and for the early detection of tumour recurrence.	—

Secondary

Measure	Time frame
1. The prognostic value of ctDNA during treatment as a biomarker for treatment response. 2. Timing and accuracy of ctDNA as a predictor for recurrence in comparison to conventional imaging. 3. The correlation of traceable mutations found in blood / saliva in comparison to mutations found in tissue biopsies, as a parameter for tumor heterogeneity. 4. The tumours* genomic status and epigenetic evolution over time under pressure of radiotherapy. 5. Sensitivity and specificity of ctDNA in blood compared to saliva. 6. The correlation between ctDNA before treatment and other clinical/biological parameters in the prediction of disease recurrence.	—

Measure

Time frame

1. The prognostic value of ctDNA during treatment as a biomarker for treatment response. 2. Timing and accuracy of ctDNA as a predictor for recurrence in comparison to conventional imaging. 3. The correlation of traceable mutations found in blood / saliva in comparison to mutations found in tissue biopsies, as a parameter for tumor heterogeneity. 4. The tumours* genomic status and epigenetic evolution over time under pressure of radiotherapy. 5. Sensitivity and specificity of ctDNA in blood compared to saliva. 6. The correlation between ctDNA before treatment and other clinical/biological parameters in the prediction of disease recurrence.

—

Countries

Netherlands

Outcome results