To assess the kinetics of ctDNA in blood and saliva before, during and after definitive radiotherapy for HNSCC and to determine the prognostic value of ctDNA as predictor for treatment response in respect to conventional imaging.
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms malignant and unspecified
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To validate ctDNA after treatment as a predictor for the presence of residual
disease and for the early detection of tumour recurrence.
Secondary outcome
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.
Background 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 tumor and can be easily assessed for measurement of different
biomarkers. However, in head and neck squamous cell carcinoma (HNSCC) patients
treated with definitive 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.
Study objective
To assess the kinetics of ctDNA in blood and saliva before, during and after
definitive radiotherapy for HNSCC and to determine the prognostic value of
ctDNA as predictor for treatment response in respect to conventional imaging.
Study design
Prospective non-randomized observational study.
Study burden and risks
Blood and saliva will be collected at regularly planned outpatient visits. This
will be once before start of treatment, at 6-7 different moments during
treatment and at five moments after end of treatment (38ml each). Tumor and
germline DNA will be analyzed using sequencing techniques. Therefore, there is
a small possibility of detection of unsolicited findings, i.e. germline DNA
variants that confer an increased risk of developing malignancies or other
diseases both for the patient and his/her family. In total, 3 extra
conventional CT scans or MRI scans will be performed during follow up. These
extra scans will be accompanied by (an acceptable amount of) radiation burden.
The possible advantages of these extra scans will be very stringent follow up,
with the possibility of more early and adequate therapeutic salvage treatment.
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Plesmanlaan 121
AMSTERDAM 1066CX
NL
Listed location countries
Age
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
• 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64571.031.18 |