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NCT Number: NCT07558889

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

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

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione Policlinico Universitario Agostino Gemelli, IRCCS

Roma, 00136, Italy

Location status: Recruiting

Location contact

Francesco Fanfani, MD

CONTACT

[email protected]

0630153421

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Disease Free Survival

    Time frame: Baseline.

    To evaluate the impact of the immuno-molecular and clinical profile of endometrial cancer on the outcomes of DFS (Disease-Free Survival).

Secondary outcomes

  1. Overall Survival

    Time frame: Baseline.

    To evaluate the impact of the immuno-molecular and clinical profile of endometrial cancer on the outcomes of OS (overall survival).

Study contacts

Contact information is provided by the study sponsor or research team.

Francesco Fanfani, MD

CONTACT

[email protected]

+390630133421

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Acronym: ENDOCancerDATA

Important dates

Study start
2024
Primary completion
2029
Study completion
2034
First posted
Apr 30, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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