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

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

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.

Study Overview

• Status: Recruiting
• Conditions: HPV-Related Carcinoma
• Intervention / Treatment: Radiation: Radiation therapy as curative treatment

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Daniela Alterio, MD; Phone Number: +390257489629; Email: daniela.alterio@ieo.it

Study Locations

• Italy
  • Milan, Italy
    • Recruiting
    • European Institute of Oncology
    • Contact: Daniela Alterio, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with HPV-related tumors; Patients with HPV-related tumors of the oropharynx, cervix, and anus	Radiation: Radiation therapy as curative treatment; Radiation therapy as curative treatment (exclusive, post-operative, with or without chemotherapy) for HPV-related squamous cell carcinomas of the oropharynx, uterine cervix, and anus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival	Number of patients with a recurrence (local or distant) after 5 years	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genetic patterns of radiosensitivity	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.	1 year

Collaborators and Investigators

• Sponsor: European Institute of Oncology
• Investigators: Principal Investigator: Daniela Alterio, European Institute of Oncology

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2023
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: March 13, 2024
• First Submitted That Met QC Criteria: March 13, 2024
• First Posted (Actual): March 20, 2024

Study Record Updates

• Last Update Posted (Actual): March 20, 2024
• Last Update Submitted That Met QC Criteria: March 13, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IEO 1811

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No