HPV-Related Carcinoma
Conditions
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).
Interventions
RADIATIONRadiation 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
Sponsors
European Institute of Oncology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disease free survival | 5 years | Number of patients with a recurrence (local or distant) after 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Italy
Contacts
Primary ContactDaniela Alterio, MD
Outcome results
None listed