ctDNA as a Biomarker for Treatment Response in HNSCC (PECAN)
Primary Purpose
Carcinoma, Squamous Cell of Head and Neck
Status
Active
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Blood draw
Sponsored by
About this trial
This is an interventional diagnostic trial for Carcinoma, Squamous Cell of Head and Neck focused on measuring ctDNA
Eligibility 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, 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).
Sites / Locations
- Antoni van Leeuwenhoek
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
blood draw
Arm Description
Blood and saliva specimens will be taken for ctDNA analysis at baseline, weekly during treatment and at 2 weeks after treatment. During follow up both blood and saliva will be obtained in combination with a CT/MRI scan on the same day at 3 months, 6 months, 1 year and 2 years after treatment.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
Levels of ctDNA at the time of corresponding conventional imaging in relation to disease occurrence.
ctDNA biomarker
The number of traceable mutations found in blood / saliva in comparison with mutations found in tissue biopsies.
ctDNA biomarker
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
Levels of ctDNA in blood compared to saliva at the same time points.
ctDNA biomarker
Levels of ctDNA before treatment compared to other clinical/biological parameters in the prediction of treatment response.
ctDNA biomarker
Full Information
NCT ID
NCT03540563
First Posted
March 14, 2018
Last Updated
October 6, 2022
Sponsor
The Netherlands Cancer Institute
1. Study Identification
Unique Protocol Identification Number
NCT03540563
Brief Title
ctDNA as a Biomarker for Treatment Response in HNSCC
Acronym
PECAN
Official Title
Prospective Study Evaluating ctDNA as a Biomarker for Treatment Response in Head and Neck Squamous Cell Carcinoma'
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 16, 2018 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Netherlands Cancer Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Squamous Cell of Head and Neck
Keywords
ctDNA
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective observational study
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
blood draw
Arm Type
Other
Arm Description
Blood and saliva specimens will be taken for ctDNA analysis at baseline, weekly during treatment and at 2 weeks after treatment. During follow up both blood and saliva will be obtained in combination with a CT/MRI scan on the same day at 3 months, 6 months, 1 year and 2 years after treatment.
Intervention Type
Other
Intervention Name(s)
Blood draw
Intervention Description
Blood will be drawn to assess ctDNA
Primary Outcome Measure Information:
Title
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.
Description
ctDNA biomarker
Time Frame
2 years
Secondary Outcome Measure Information:
Title
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.
Description
ctDNA biomarker
Time Frame
2 years
Title
Levels of ctDNA at the time of corresponding conventional imaging in relation to disease occurrence.
Description
ctDNA biomarker
Time Frame
3 years
Title
The number of traceable mutations found in blood / saliva in comparison with mutations found in tissue biopsies.
Description
ctDNA biomarker
Time Frame
3 years
Title
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.
Description
ctDNA biomarker
Time Frame
3 years
Title
Levels of ctDNA in blood compared to saliva at the same time points.
Description
ctDNA biomarker
Time Frame
At study completion, after 3 years
Title
Levels of ctDNA before treatment compared to other clinical/biological parameters in the prediction of treatment response.
Description
ctDNA biomarker
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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, 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abrahim Al-Mamgani, MD, PhD
Organizational Affiliation
Antoni van Leeuwenhoek
Official's Role
Principal Investigator
Facility Information:
Facility Name
Antoni van Leeuwenhoek
City
Amsterdam
ZIP/Postal Code
1066CX
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Patients sign for participation in this study and not for use in other studies
Learn more about this trial
ctDNA as a Biomarker for Treatment Response in HNSCC
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