Neoplasms

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

All Conditions

Oropharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

This study is an observational study evaluating the clinical outcomes of mucosal sparing proton beam therapy (PBT) after resection of favorable risk oropharyngeal cancer patients. Subjects will be screened at outpatient clinic visit appointments and interested qualified subjects will be consented and offered participation in this study. Once consent has been obtained baseline adverse event and Quality of Life (QOL) data will be collected and subjects will undergo adjuvant PBT and follow-up at 3 months, 12 months, and 24 months. No study-specific visits or evaluations will be required. Patients will be evaluated according to the physician's standard practice and discretion. Patient data will be drawn from the patients' medical records and reported by means of a web-based electronic data collection (EDC) system. Patients will be considered "on study" until 24 months of observation has occurred, withdrawal of consent, lost to follow-up, or study closure.

A Study of Mucosal Sparing Proton Beam Therapy (PBT) in Resected Oropharyngeal Tumors

Local control rate will be assessed by standard of care head and neck clinical examination during routine followup visits

Mayo Clinic

Assistant Professor of Radiation Oncology

Symptoms and General Pathology

Infections

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Carcinoma

Carcinoma, Squamous Cell

Neoplasm Metastasis

Communicable Diseases

Virus Diseases

Papillomavirus Infections

Papilloma

Lymphatic Metastasis

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neoplasms, Squamous Cell

Neoplastic Processes

Sexually Transmitted Diseases

Sexually Transmitted Diseases, Viral

DNA Virus Infections

Tumor Virus Infections

Genital Diseases

Urogenital Diseases

Disease Attributes

The prospective observational study involves the collection of tissue, blood and saliva samples from OPSCC and occult T patients for detection of HPV-DNA/RNA, miRNA and mutation profile from DNA with centralized analysis of samples at IRCCS Regina Elena National Cancer Institute.

Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx

Raul Pellini, Doctor

Raul Pellini, MD

Based on the evidence summarized in the introduction, the clinician hypothesize that the detection of the presence and expression of HPV-DNA, certain miRNAs, and a certain mutational profile in the tissues and biological fluids of these patients, may have important prognostic and diagnostic value not only in HPV-related OPSCCs but also in HPV+ occult T. Accordingly, this study aims to aim to better characterize their potential as biomarkers and to detect the possibility of their their use to implement the sensitivity and specificity of radiological methodologies (PET-CT and MRI), already in use in clinical practice, for monitoring disease progression in this specific subgroup. Finally, by using the collected material to generate organoids and Patient Derived Xenograft (PDX), the study also aims to identify possible new molecular drugs, which could solve the problem of resistance to radiochemotherapy.

Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus

Investigating the kinetics of HPV-DNA and miRNAs in patients with oropharyngeal and occult T tumors with laterocervical metastasis. Conducting this study will allow us to collect the information needed to be able to generate hypotheses and design a subsequent larger study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Mucosal Sparing Proton Beam Therapy (PBT) in Resected Oropharyngeal Tumors	NCT02736786	Oropharyngeal T...		18 Years -	Mayo Clinic
A Study of Mucosal Sparing Proton Beam Therapy (PBT) in Resected Oropharyngeal Tumors	NCT02736786	Oropharyngeal T...		18 Years -	Mayo Clinic
Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus	NCT05918510	Squamous Cell C... Carcinomas of U... High-risk Human... Liquid Biopsy Lymph Node Meta... Occult Tumor of...	Study of Viral ...	18 Years -	Regina Elena Cancer Institute
Observational Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx and Occult Tumors Positive for Papilloma Virus	NCT05918510	Squamous Cell C... Carcinomas of U... High-risk Human... Liquid Biopsy Lymph Node Meta... Occult Tumor of...	Study of Viral ...	18 Years -	Regina Elena Cancer Institute

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