HPV-Related CarcinomaICARUSNCT06321627
Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach
An observational study of HPV-Related Carcinoma, run by European Institute of Oncology at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HPV-Related Carcinoma
- What is being tested?
- Radiation therapy as curative treatment
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- 14 Apr 2023to 31 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HPV-positive tumors of the oropharynx, uterine cervix, and anus
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan
Daniela Alterio, MD
About this study
Official title: Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach - ICARUS Project
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.
Read the 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:
- investigate the role of Cl2 in non-oropharyngeal HPV-related tumors, and
- 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).
- Conditions
- HPV-Related Carcinoma
- Being tested
- Radiation therapy as curative treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiation therapy as curative treatmentRadiation
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with HPV-related tumors | Patients with HPV-related tumors of the oropharynx, cervix, and anus Receives: Radiation: Radiation therapy as curative treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease free survival
Number of patients with a recurrence (local or distant) after 5 years
Measured: 5 years
Secondary outcomes (1)
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start14 Apr 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HPV-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniela Alterio, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321627
- Sponsor's protocol ID
- IEO 1811
- Acronym
- ICARUS
- Status last verified
- Mar 2024
- First submitted
- 13 Mar 2024
- Last updated
- 20 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach - ICARUS Project
- ClinicalTrials.gov ID
- NCT06321627
- Acronym / sponsor ID
- ICARUS / IEO 1811
- Conditions
- HPV-Related Carcinoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- investigate the role of Cl2 in non-oropharyngeal HPV-related tumors, and
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with HPV-related tumors | – | Radiation: Radiation therapy as curative treatmentPatients with HPV-related tumors of the oropharynx, cervix, and anus |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HPV-positive tumors of the oropharynx, uterine cervix, and anus
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiation therapy as curative treatmentRadiation therapy as curative treatment (exclusive, post-operative, with or without chemotherapy) for HPV-related squamous cell carcinomas of the oropharynx, uterine cervix, and anus | Radiation | Patients with HPV-related tumors |
Primary outcome
Disease free survival
Time frame: 5 years
Number of patients with a recurrence (local or distant) after 5 years
1 secondary outcome
Genetic patterns of radiosensitivity
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniela Alterio principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV-Related Carcinoma, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniela Alterio, MD (+390257489629, daniela.alterio@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disease free survival (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2024.