Actively Recruiting
Observational Study of Viral Biomarkers and microRNAs in Oropharyngeal and Occult Tumors Positive for Papilloma Virus
Led by Regina Elena Cancer Institute · Updated on 2023-10-10
142
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
Sponsors
R
Regina Elena Cancer Institute
Lead Sponsor
I
Istituto Clinico Humanitas
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research aims to better understand the role of viral biomarkers, microRNAs, and specific mutation profiles in tumors of the oropharynx and occult tumors positive for human papillomavirus (HPV). Researchers want to explore how these markers can improve diagnostic and prognostic accuracy, especially when combined with imaging methods like PET-CT and MRI. The study also seeks to develop organoids and patient-derived xenografts to identify new molecular drugs that might overcome resistance to radiochemotherapy. The study involves collecting tissue, blood, and saliva samples from patients with oropharyngeal squamous cell carcinoma and occult tumors with lymph node metastases. These samples will be analyzed centrally to detect HPV-DNA/RNA, microRNAs, and mutation profiles. Patients are grouped based on different microRNA expression levels, including a control group. This is an observational study without intervention, focusing on biomarker detection and analysis. Participants will provide biological samples and complete questionnaires during the study. Researchers will monitor the accuracy of biomarker detection at baseline and assess how these markers correlate with disease progression using radiological imaging. The study includes patients aged 18 and older with specific cancer types and performance status allowing participation. The involvement period varies based on clinical follow-up and sample collection schedules.
CONDITIONS
Brief Title
Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged over 18 years
- Diagnosed with squamous cell carcinoma of the oropharynx or occult tumors with lymph node metastases treated with TORS, radiotherapy, or chemoradiotherapy
- ECOG performance status of 2 or lower
- Able to follow study procedures and complete questionnaires
- Signed informed consent
You will not qualify if you...
- Presence of distant metastases at diagnosis
- Previous head and neck cancer
- Another tumor under treatment or follow-up for less than 5 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At baseline
Participants provide tissue, blood, and saliva samples for detection of HPV-DNA/RNA, microRNA, and DNA mutation profiling.
1 baseline visit (in-person) for sample collection
Duration - Up to 5 years
Participants are observed over time to assess viral biomarkers and microRNA profiles related to oropharyngeal and occult tumors.
Follow-up visits as per routine clinical care
Trial Site Locations
Total: 1 location
1
"Regina Elena" National Cancer Institute
Rome, Italy, 00144
Actively Recruiting
Research Team
R
Raul Pellini, Doctor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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