Surgical and Obstetric Outcomes in Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia With Conservative Treatment
Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Jul 12, 2025
Trial Information
Current as of July 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying women diagnosed with early-stage womb (endometrial) conditions called endometrial adenocarcinoma or atypical endometrial hyperplasia. These conditions affect the lining of the uterus and can sometimes be treated without removing the uterus, which is important for women who want to preserve their ability to have children or who cannot undergo major surgery for health reasons. The study focuses on women who have received a conservative treatment that involves a special surgery to remove abnormal tissue through a small camera inserted into the uterus, followed by hormone therapy. The researchers want to learn more about how well this treatment works and whether patients can safely become pregnant afterward.
Women aged 18 or older who have been diagnosed with these specific uterine conditions and who have had this type of conservative treatment performed at the CLASS Hysteroscopy Center in Rome may be eligible to join. Participants will be followed for 12 months to monitor their health and any pregnancy outcomes. It’s important that participants have no other causes of infertility and agree to take part by signing a consent form. This study helps doctors understand the chances of successful pregnancy and cancer control with less invasive treatment options, offering hope for women who need alternatives to standard surgery.
Gender
FEMALE
Eligibility criteria
- Inclusion Criteria:
- • Female patients aged 18 years or older.
- • Histological diagnosis of endometrial adenocarcinoma (EAC) or atypical endometrial hyperplasia (AEH).
- • Patients who underwent conservative treatment with hysteroscopic resection at the CLASS Hysteroscopy Center, performed by a single experienced surgeon (U.C.).
- • Patients treated conservatively due to medical contraindications to radical surgery (e.g., severe comorbidities).
- • Signed informed consent for participation in the study.
- Exclusion Criteria:
- • Patients with other known causes of infertility.
- • Patients with non-endometrioid histological subtypes of endometrial adenocarcinoma.
- • Patients under 18 years of age.
- • Patients who did not provide informed consent for participation.
About Fondazione Policlinico Universitario Agostino Gemelli Irccs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Roma, , Italy
Patients applied
Trial Officials
Ursula Catena
Principal Investigator
Fondazione Policlinico Universitario A. Gemelli, IRCCS
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported