Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach

HPV-Related Carcinoma Clinical Trial

— ICARUS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06321627
• Other study ID #: IEO 1811
• Status: Recruiting
• Start date: April 14, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: European Institute of Oncology
• Contact: Daniela Alterio, MD
• Phone: +390257489629
• Email: daniela.alterio[@]ieo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• HPV-Related Carcinoma

Intervention

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

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (1)

Lead Sponsor	Collaborator
European Institute of Oncology

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Disease free survival	Number of patients with a recurrence (local or distant) after 5 years	5 years
Secondary	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