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

NCT06774482 | Recruiting

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

Brief 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.

Conditions

Uterine Neoplasms

Outcome Measures

Primary Outcomes (1)

• Local disease recurrence

  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.

  From the end of therapy to the last follow-up at 12 months

Secondary Outcomes (5)

• Acute toxicity

  immediate to 6 months after radiotherapy

• Late toxicity

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

• Incidence of retreatments and their characteristics

  During follow ups through study completion, an average of 1 year

• Disease-free survival of the patients

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

• Overall survival

  From enrollment to the last follow-up ar 12 months

Eligibility Criteria

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

Study Population

Female patients, aged ≥ 18 years, with a new or previous diagnosis of malignant uterine neoplasm

You may qualify if:

• 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

You may not qualify if:

• 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

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

Uterine Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

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: May 19, 2021
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: January 14, 2025

Record last verified: 2024-10

Locations

IT (1)