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

NCT06773039 | Recruiting

• 1 other identifier: PORTO
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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

Head and Neck Cancer

Outcome Measures

Primary Outcomes (1)

• Evaluate the correlation of therapy response

  Evaluate the correlation of therapy response with other parameters in the radiotherapy treatment of head and neck neoplasms, considering the treatment setting, dosages, and techniques used

  From enrollment to the last follow-up at 12 months

Secondary Outcomes (6)

• Acute toxicity

  immediate to 6 months after radiotherapy

• Late toxicity

  from 6 months after radiotherapy, through study completion, an average of 1 year

• Impact on the patient's quality of life

  From enrollment to the last follow-up at 12 months

• Retreatments

  During the follow-ups, up to the last one at 12 months

• Disease-free survival

  During the follow-ups, up to the last one at 12 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with new or previous diagnosis of malignant neoplasm of the head and neck

You may qualify if:

• Patients of both sexes, aged ≥ 18 years, with new or previous diagnosis of malignant neoplasm of the head and neck, from January 1, 2000, treated at the Radiotherapy Unit of the S. Orsola Polyclinic
• Obtaining informed consent

You may not qualify if:

• None

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero - Universitaria di Bologna

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Study Officials

• Alessio Giuseppe Morganti, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alessio Giuseppe Morganti, MD

CONTACT

+39 0516363136; alessio.morganti2@unibo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: January 14, 2025
• Study Start: October 28, 2021
• Primary Completion (Estimated): November 15, 2030
• Study Completion (Estimated): December 15, 2030
• Last Updated: January 14, 2025

Record last verified: 2024-10

Locations

IT (1)