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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

142 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-04

Study Completion Date

2029-04-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Squamous Cell Carcinoma of the Oropharynx Carcinomas of Unknown Primary Site High-risk Human Papillomavirus Infection Liquid Biopsy Lymph Node Metastasis Occult Tumor of the Head and Neck Area

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

High miR value

Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx

Intervention Type DIAGNOSTIC_TEST

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.

Group 2

Control group

Study of Viral BIOmarkers and microRNAs in Tumors Orofarynx

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No