Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach

Recruiting

• Conditions: HPV-Related Carcinoma
• Interventions: Radiation: Radiation therapy as curative treatment

• Registration Number: NCT06321627
• Lead Sponsor: European Institute of Oncology

Brief Summary

The purpose of this study is therefore to analyze the genomic profiles of prognosis and radiosensitivity of Human Papilloma Virus (HPV) related tumors from different body sites (oropharynx, uterine cervix, and anus), considering them as a unified entity regardless of the site of origin within the body.

Detailed Description

The present study (ICARUS - genomIC RAdiosensitivity viRUS) involves the collection of data (retrospective and prospective) from an extensive cohort of patients with HPV-related tumors of the oropharynx, cervix, and anus.

The aim is to:

1. investigate the role of Cl2 in non-oropharyngeal HPV-related tumors, and

2. compare the Radiation Sensitivity Index (RSI) values of HPV-related tumors in patients who responded to radiotherapy (responders) with those of patients with radioresistant tumors (non-responders).

Study Timeline

• Study Start: 2023-04-14
• Status Verified: 2024-03
• Study First Submitted: 2024-03-13
• Study First Submitted QC: 2024-03-13
• Last Update Submitted: 2024-03-13
• Study First Posted: 2024-03-20
• Last Update Posted: 2024-03-20
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Adult patients (>18 years old)
• Diagnosis of HPV-related squamous cell carcinomas of the oropharynx, uterine cervix, and anus
• Curative intent radiation therapy (exclusive, post-operative, with or without chemotherapy)
• Availability of pre-radiation therapy biopsy sample
• No diagnosis of solid neoplasms and/or hematologic malignancies in the previous 5 years
• Possibility of retrospective and prospective data collection and anonymous submission to the referring center of clinical data related to the patient, pathology, and treatment characteristics (including radiation treatment plan in RT.dose format)
• Ability to obtain written informed consent for the use of data anonymously for research purposes

Exclusion Criteria

• Patients undergoing surgical treatment
• Patients with local and/or locoregional recurrence
• Patients with synchronous distant metastases at diagnosis
• Patients previously treated with oncologic therapies for tumors of the same anatomical site

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with HPV-related tumors	Radiation therapy as curative treatment	Patients with HPV-related tumors of the oropharynx, cervix, and anus

Primary Outcome Measures

Name	Time	Method
Disease free survival	5 years	Number of patients with a recurrence (local or distant) after 5 years

Secondary Outcome Measures

Name	Time	Method
Genetic patterns of radiosensitivity	1 year	The biopsy samples from patients included in the database will be collected for the validation analyses of RadioSensitivity Index (RSI). The calculation of RSI will be performed using a panel of 10 genes extracted from the tumor biopsy.

Trial Locations

Locations (1)

European Institute of Oncology; 🇮🇹 Milan, Italy