Analyzing the genomic profiles of HPV-related tumors and their response to radiation
Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach - ICARUS Project
This study is trying to see how the genetic makeup of HPV-related tumors affects their response to radiation treatment in patients with tumors in different parts of the body.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | European Institute of Oncology Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Milan) |
| Trial ID | NCT06321627 on ClinicalTrials.gov |
What this trial studies
This observational study aims to analyze the genomic profiles of HPV-related tumors from various body sites, including the oropharynx, cervix, and anus, treating them as a unified entity. It will collect both retrospective and prospective data from a large cohort of patients to investigate the role of Cl2 in non-oropharyngeal HPV-related tumors. Additionally, the study will compare the Radiation Sensitivity Index (RSI) values between patients who respond to radiotherapy and those who do not, providing insights into the radiosensitivity of these tumors.
Who should consider this trial
Good fit: Ideal candidates for this study are adult patients over 18 years old diagnosed with HPV-related squamous cell carcinomas of the oropharynx, cervix, or anus who are undergoing curative intent radiation therapy.
Not a fit: Patients who may not benefit from this study include those undergoing surgical treatment, those with local or locoregional recurrence, or those with distant metastases at diagnosis.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment strategies for patients with HPV-related carcinomas by identifying genomic factors that influence radiosensitivity.
How similar studies have performed: Other studies have shown promise in analyzing genomic profiles for treatment responses in cancer, suggesting that this approach may yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Milan
- European Institute of Oncology — Milan, Italy (Recruiting)
Study contacts
- Principal investigator: Daniela Alterio — European Institute of Oncology
- Study coordinator: Daniela Alterio, MD
- Email: daniela.alterio@ieo.it
- Phone: +390257489629
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.