Assessment of Different Therapeutic Strategies in Patients With Head and Neck Neoplasms Treated With Radiotherapy

NCT06773039 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 3000

Last updated 2025-01-14

No results posted yet for this study

Summary

This is a monocentric observational study aimed at collecting data related to the radiotherapy treatment of head and neck neoplasms. The purpose of the study is to systematically gather data on radiotherapy for head and neck neoplasms to evaluate tumor response and potential toxicity in relation to dosages and techniques used, the combination with other therapies, disease characteristics, and the psychological impact of the proposed treatments.

Additionally, collecting data on both disease characteristics and pre-existing conditions in a large sample may allow for the assessment of any correlation with radiation-induced toxicities, with the goal of predicting and preventing them in a personalized manner in the future.

The study's aim is thus to evaluate tumor response and any potential toxicity following radiotherapy treatment concerning treatment modalities, dosages, and techniques used, for both new diagnoses and cases already diagnosed and treated since January 1, 2000, at the Radiotherapy Unit of the S. Orsola-Malpighi Polyclinic. The structured data collection necessary for evaluating the objectives will cover the observation period from January 1, 2000, to December 15, 2030, involving approximately 3,000 patients. Participation in the study solely involves the structured collection of certain information already present in your medical records, as well as data related to clinical exams, radiological imaging, and therapies, without any modifications to standard clinical practice. Participation in the study incurs no costs and will not be compensated in any way. There are no risks or inconveniences associated with participating in this study. Enrolled patients will not receive any direct benefit from this study, as it is purely a data collection effort. The collected data will enhance understanding of the factors associated with treatment outcomes, ultimately leading to improved management of each individual patient.

Conditions

Sponsors & Collaborators

  • IRCCS Azienda Ospedaliero-Universitaria di Bologna

    lead OTHER

Principal Investigators

  • Alessio Giuseppe Morganti, MD · IRCCS Azienda Ospedaliero-Universitaria di Bologna

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-10-28
Primary Completion
2030-11-15
Completion
2030-12-15

Countries

  • Italy

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06773039 on ClinicalTrials.gov