Radiosensitivity of HPV-related Tumors: Towards a Genomic Approach

NCT ID: NCT06321627

Last Updated: 2024-03-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-04-14

Study Completion Date

2024-12-31

Brief Summary

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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

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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).

Conditions

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HPV-Related Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with HPV-related tumors

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

Radiation therapy as curative treatment

Intervention Type 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

Interventions

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Radiation 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

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Institute of Oncology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniela Alterio

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

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European Institute of Oncology

Milan, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Daniela Alterio, MD

Role: CONTACT

+390257489629

Facility Contacts

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Daniela Alterio, MD

Role: primary

Other Identifiers

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IEO 1811

Identifier Type: -

Identifier Source: org_study_id

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