NCT06806683Active, not recruiting
Predictive Tools in Head and Neck Cancer Patients Undergoing Radiotherapy
ITHACA: Development and Validation of a Multivariate Predictive Model for Prognosis in Head and Neck Cancer Patients Undergoing Radiotherapy - Ambispective Study.
Source: ClinicalTrials.gov · Last updated 4 Feb 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 915 (estimated)
- First submitted
- 21 Oct 2024
- Start date
- 1 Jan 2023
- Primary completion date
- 31 Dec 2034
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Diseases
- Head and neck cancer
- NCT number
- NCT06806683
What you commit to
- Study type: Observational
- Planned participants: 915
- From 1 Jan 2023 to the primary completion date, 31 Dec 2034
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.