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

Lymph Node Metastasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05918510
• Other study ID #: RS1647/22
• Status: Recruiting
• Start date: April 4, 2022
• Est. completion date: April 4, 2029

Study information

• Verified date: June 2023
• Source: Regina Elena Cancer Institute
• Contact: Raul Pellini, Doctor
• Phone: 06-52664484
• Email: raul.pellini[@]ifo.gov.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 142
• Est. completion date: April 4, 2029
• Est. primary completion date: April 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Squamous cell carcinomas of the oropharynx and occult neoplasms with lymph node metastases laterocervical cytologically positive for squamous cell carcinoma treated with TORS or RT or RT/CT
• Age > 18 years
• ECOG performance status <_ 2
• Ability to follow study procedures and complete questionnaires
• Signature of informed consent

Exclusion Criteria:

• Presence of distant metastases at the time of diagnosis
• Previous cancer of the head and neck district
• Second tumor in therapy or follow-up for less than 5 years

Related Conditions & MeSH terms

• Carcinoma
• Head and Neck Neoplasms
• Liquid Biopsy
• Lymph Node Metastasis
• Lymphatic Metastasis
• Papilloma
• Papillomavirus Infections
• Squamous Cell Carcinoma of the Oropharynx

Intervention

Diagnostic Test:
• Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx
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.

Locations

Country	Name	City	State
Italy	"Regina Elena" National Cancer Institute	Rome

Sponsors (7)

Lead Sponsor	Collaborator
Regina Elena Cancer Institute	Azienda Policlinico Umberto I, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Istituto Clinico Humanitas, Istituto Europeo di Oncologia, University of Firenze and Siena, Napoli, Italy, Weizmann Institute of Science

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accouracy	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.	Baseline