Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach (ICARUS)

European Institute of Oncology

Status: Enrolling

Conditions: HPV-Related Carcinoma

Treatments: Radiation: Radiation therapy as curative treatment

Study type: Observational

Funder types: Other

Identifiers

NCT06321627

IEO 1811

Details and patient eligibility

About

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.

Full 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).

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

100 participants in 1 patient group

Patients with HPV-related tumors

Description:

Patients with HPV-related tumors of the oropharynx, cervix, and anus

Treatment:

Radiation: Radiation therapy as curative treatment