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PECAN: ctDNA as a Biomarker for Treatment Response in HNSCC

Sponsor
The Netherlands Cancer Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03540563
Collaborator
(none)
70
Enrollment
1
Location
1
Arm
45.5
Anticipated Duration (Months)
1.5
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood draw
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
70 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Prospective observational studyProspective observational study
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Prospective Study Evaluating ctDNA as a Biomarker for Treatment Response in Head and Neck Squamous Cell Carcinoma'
Actual Study Start Date :
Jul 16, 2018
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Other: blood draw

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.

Other: Blood draw
Blood will be drawn to assess ctDNA

Outcome Measures

Primary Outcome Measures

  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. [2 years]

    ctDNA biomarker

Secondary Outcome Measures

  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. [2 years]

    ctDNA biomarker

  2. Levels of ctDNA at the time of corresponding conventional imaging in relation to disease occurrence. [3 years]

    ctDNA biomarker

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

    ctDNA biomarker

  5. Levels of ctDNA in blood compared to saliva at the same time points. [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. [3 years]

    ctDNA biomarker

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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).

Contacts and Locations

Locations

Site City State Country Postal Code
1 Antoni van Leeuwenhoek Amsterdam Netherlands 1066CX

Sponsors and Collaborators

  • The Netherlands Cancer Institute

Investigators

  • Principal Investigator: Abrahim Al-Mamgani, MD, PhD, Antoni van Leeuwenhoek

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
The Netherlands Cancer Institute
ClinicalTrials.gov Identifier:
NCT03540563
Other Study ID Numbers:
  • N18PCN
First Posted:
May 30, 2018
Last Update Posted:
Aug 4, 2021
Last Verified:
Aug 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by The Netherlands Cancer Institute
ctDNA
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck

Study Results

No Results Posted as of Aug 4, 2021