Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach

NCT06321627 | Recruiting

• 1 other identifier: IEO 1811
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

HPV-Related Carcinoma

Outcome Measures

Primary Outcomes (1)

• Disease free survival

  Number of patients with a recurrence (local or distant) after 5 years

  5 years

Secondary Outcomes (1)

• Genetic patterns of radiosensitivity

  1 year

Study Arms (1)

Patients with HPV-related tumors

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

Radiation: Radiation therapy as curative treatment

Interventions

Radiation therapy as curative treatment RADIATION

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

Patients with HPV-related tumors

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• European Institute of Oncology: lead

Study Sites (1)

European Institute of Oncology

Milan, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Tumor biopsy

MeSH Terms

Interventions

Radiotherapy

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Daniela Alterio

  European Institute of Oncology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela Alterio, MD

CONTACT

+390257489629; daniela.alterio@ieo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 20, 2024
• Study Start: April 14, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 20, 2024

Record last verified: 2024-03

Locations

IT (1)