Clinical trial · Observational
Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach
Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach - ICARUS Project
NCT06321627CI-TRIAL-00075244ICARUSunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| HPV-Related Carcinoma | Human Papillomavirus-Related Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Radiation therapy as curative treatment | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with HPV-related tumors
- description
- Patients with HPV-related tumors of the oropharynx, cervix, and anus
- interventionNames
- Radiation: Radiation therapy as curative treatment
Primary outcomes (1)
- measure
- Disease free survival
- timeFrame
- 5 years
- description
- Number of patients with a recurrence (local or distant) after 5 years
Secondary outcomes (1)
- measure
- Genetic patterns of radiosensitivity
- timeFrame
- 1 year
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.