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Recruiting Observational

Evaluation of Toxicity and Outcomes of Different Therapeutic Strategies in Patients With Uterine Neoplasms

NCT06774482 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2021-05-19
Last updated
2025-01-14

Condition(s) studied

Uterine Neoplasms

Study summary

The single-center observational study aims to collect data related to the radiation treatment of uterine neoplasms. The purpose of the study is to systematically gather data on radiation treatment in uterine neoplasms in order to evaluate tumor response and potential toxicity in relation to dosages, fractionation, and techniques used, as well as the combination with other therapies and the characteristics of the disease.

Additionally, collecting data on both the characteristics of the disease and patients' comorbidities in a large sample may allow for the evaluation of any possible correlation with radiation-induced toxicities, with the aim of being able to predict and prevent them in a personalized manner in the future.

Therefore, the study's goal is to evaluate tumor response and any potential toxicity after radiotherapy treatment in relation to treatment settings, dosages, and techniques used, both for new diagnoses and for cases already diagnosed and treated from 01/01/2000 onwards at the Radiotherapy Unit of Sant'Orsola-Malpighi Polyclinic.

The structured collection of data necessary for the evaluation of the objectives will cover the observation period from 01/01/2000 to 15/12/2030, for a total of approximately 5000 patients.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Female patients, aged ≥ 18 years, with a new or previous diagnosis of malignant uterine neoplasm, starting from 01/01/2000, treated at the Radiotherapy Unit of the Sant'Orsola Polyclinic * Obtaining informed consent Exclusion Criteria: * Patients with a new or previous diagnosis of malignant uterine neoplasm who choose not to undergo radiation treatment at the Radiotherapy Unit of the Sant'Orsola Polyclinic

Primary outcome measure(s)

  • Local disease recurrence — From the end of therapy to the last follow-up at 12 months
    To evaluate the outcome, particularly in terms of local disease recurrence, after radiation treatment of uterine neoplasms, in relation to the treatment setting, dosages, and techniques used, both for newly diagnosed neoplasms and for cases already diagnosed and treated since 01/01/2000 at the Sant'Orsola Polyclinic, Bologna University Hospital.

Trial sites (1)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero - Universitaria di Bologna Bologna Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06774482 on ClinicalTrials.gov ↗ ← All trials in Italy