Predictive Tools in Head and Neck Cancer Patients Undergoing Radiotherapy

NCT ID: NCT06806683

Last Updated: 2025-02-04

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

ACTIVE_NOT_RECRUITING

Total Enrollment

915 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2039-12-31

Brief Summary

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The ITHACA study aims to improve the treatment of head and neck cancer by developing a predictive tool that helps doctors personalize care for each patient. This tool uses information such as medical history, imaging, and radiotherapy data to predict the risk of cancer recurrence, overall survival, and the likelihood of side effects.

Patients with head and neck cancer face significant challenges, including managing the side effects of treatments like radiotherapy. By tailoring treatment schedules and doses, and using advanced imaging techniques, we hope to reduce complications and improve survival outcomes. The study is designed to help doctors choose the best treatment for each patient, while minimizing the side effects that impact important functions like swallowing and breathing.

Patients participating in the study will have their medical data collected, including:

Tumor characteristics (size, location, stage). Treatment details (radiotherapy and chemotherapy). Imaging information using tools like PET-CT and MRI to track the response to treatment and detect any signs of cancer recurrence.

Side effects and overall health data. This information will be used to develop and test a new model that predicts outcomes for each patient based on their unique data.

The study includes adults (18 years and older) diagnosed with head and neck cancer, who are undergoing or have completed radiotherapy. Patients will be followed over time to monitor their response to treatment and any side effects.

Detailed Description

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Conditions

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Head and Neck Cancers Head and Neck Cancers - Nasopharyngeal Oral Cavity Cancer Oropharyngeal Cancers Radiotherapy Side Effects

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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intensity modulated radiotherapy

intensity modulated radiotherapy

Intervention Type RADIATION

Eligibility Criteria

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Inclusion Criteria

Participants must meet all of the following criteria:

* Diagnosis: Confirmed head and neck cancer, including cancers of the oropharynx, larynx, hypopharynx, nasopharynx, salivary gland, unknown head and neck primary or oral cavity.
* Age: 18 years or older.
* Treatment: Undergoing or scheduled to undergo radiotherapy or chemoradiotherapy as part of their treatment

Exclusion Criteria

Participants will be excluded if they meet any of the following criteria:

* Pregnancy: Pregnant or breastfeeding women.
* Non-Compliance: Patients unwilling or unable to comply with study procedures and follow-ups.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mariangela Massaccesi, MD

Role: PRINCIPAL_INVESTIGATOR

Fondazione Policlinico Universitario A. Gemelli, IRCCS

Locations

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, Italy

Site Status

Countries

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Italy

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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6698

Identifier Type: -

Identifier Source: org_study_id

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