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Trial Title:
Can Recurrence of Cancer in the Oropharynx Be Detected by Blood Samples?
NCT ID:
NCT06592716
Condition:
Oropharyngeal Squamous Cell Carcinoma (SCC)
Oropharynx Cancer
Oropharynx Cancer, Metastatic
Oropharynx Cancer, Recurrent
Oropharyngeal Carcinoma
Conditions: Official terms:
Carcinoma
Carcinoma, Squamous Cell
Squamous Cell Carcinoma of Head and Neck
Oropharyngeal Neoplasms
Conditions: Keywords:
HPV
HPV-DNA
Liquid biopsy
cell-free HPV-DNA
circulating HPV-DNA
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
Liquid biopsy
Description:
The intervention is a liquid biopsy as a blood sample taken in a peripheral vein. The
blood samples are analyzed for cell free HPV-DNA.
Arm group label:
Identify recurrence
Summary:
This study investigates if longitudinal analyses of cell-free HPV-DNA in blood samples
can be utilized to detect recurrence in patients diagnosed and treated for HPV-positive
oropharyngeal squamous cell carcinoma.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with newly diagnosed HPV+ (or p16+) OPSCC carcinoma originating from the
oropharynx
- Above 18 years of age
- Informed consent
- Patients offered curative treatment.
Exclusion Criteria:
- The patient does not speak or understand Danish
- The patient has another disease/condition considered a reason for exclusion
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Department of Otorhinolaryngology, Head and Neck Surgery and Audiology
Address:
City:
Copenhagen
Country:
Denmark
Status:
Recruiting
Contact:
Last name:
Simone Kloch Bendtsen, MSc, PhD
Phone:
+4520549626
Email:
diagnostikiblod.rigshospitalet@regionh.dk
Start date:
April 2, 2024
Completion date:
December 31, 2028
Lead sponsor:
Agency:
Rigshospitalet, Denmark
Agency class:
Other
Collaborator:
Agency:
Copenhagen University Hospital, Denmark
Agency class:
Other
Collaborator:
Agency:
Department of Otorhinolaryngology, Head and Neck Surgery and Audiology
Agency class:
Other
Source:
Rigshospitalet, Denmark
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06592716