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Recruiting NCT07558889

The Surveillance, Epidemiology, and End Results Database Program on Endometrial Cancer in the Italian Population

Observational Endometrium Cancer Gynecologic Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Endometrium Cancer, Gynecologic Cancer. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Italy
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

The ENDOCancer-DATA: the Surveillance, Epidemiology, and End Results Database Program on Endometrial Cancer in the Italian Population

Overview

The aim of this study is to lay the bases for an ambitious project that reports and records all the epidemiological-clinical information of the cases of endometrial carcinoma diagnosed and treated in the reference oncology centers involved on the national territory, to create a process of analysis of the data

Detailed description

Endometrial cancer represents the most common gynecological cancer in industrialized countries and the fourth most common neoplasm after breast, lung and colorectal cancer. Unlike other neoplasms, its incidence and mortality are continuously increasing. In this context, the National Health System requires an optimization of the diagnosis and treatment strategies of this carcinoma. This aspect leads a continuous effort to improve to properly manage the impact that this disease has on female health in Italy. Throughout the world, there are national, supranational models and registers aimed at establishing and managing over time an archive of all newly diagnosed cancer cases, ensuring that data recording takes place in a rigorous, continuous and systematic manner. An excellent example of this is the SEER of the National Cancer Institute of America, which has the task of recording and monitoring the epidemiological-clinical data of various carcinomas, to monitor the clinical progress and management of therapeutic programs of neoplastic pathologies. This program represents the epidemiological and statistical basis of important scientific evidence, both prospective and retrospective, aimed at reporting and demonstrating the effectiveness of preventive, diagnostic and therapeutic approaches in the various oncological pathologies examined.

On these premises, the aim of this study is to lay the bases for an ambitious project that reports and records all the epidemiological-clinical information of the cases of endometrial carcinoma diagnosed and treated in the reference oncology centers involved on the national territory, to create a process of analysis of the data

Primary outcome measures

  • Disease Free Survival [Time frame: Baseline.]
Secondary outcome measures (1)
  • Overall Survival [Time frame: Baseline.]

Eligibility criteria

Inclusion criteria

  • diagnosis of endometrial cancer (stage I-IV, G1-3, and special histotypes)
  • age > 18 years
  • American Society of Anesthesiologists classification (ASA score) 1-3
  • patients undergoing staging, cytoreduction or diagnostic surgery with acquisition of histological examination on which IHC and/or NGS studies have been performed for the molecular profile of the carcinoma
  • Signed informed consent

Exclusion criteria

  • patients with missing information
  • patients not treated in the participating centers for which only partial and fragmented information will be available
  • molecular profile not known and\\or not recoverable and retrospectively analysable

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Italy · 1 center
  • Fondazione Policlinico Universitario Agostino Gemelli, IRCCS — Roma

Identifiers

NCT: NCT07558889 · 6168

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗