NCT07077876 Surgical and Obstetric Outcomes in Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia With Conservative Treatment
| NCT ID | NCT07077876 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS |
| Condition | Endometrial Adenocarcinoma |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-06-20 |
| Primary Completion | 2025-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2025-06-20 with a primary completion date of 2025-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This observational study aims to evaluate the obstetric and oncological outcomes of patients diagnosed with endometrial adenocarcinoma (EAC) or atypical endometrial hyperplasia (AEH) who underwent conservative treatment at the CLASS Hysteroscopy Center of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome. Eligible patients include women who received hysteroscopic surgery and hormonal therapy either to preserve fertility or due to medical contraindications to standard radical surgery. Follow-up lasts 12 months.
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.
Contact & Investigator
Ursula Catena
PRINCIPAL INVESTIGATOR
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Frequently Asked Questions
Who can join the NCT07077876 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Endometrial Adenocarcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07077876 currently recruiting?
Yes, NCT07077876 is actively recruiting participants. Contact the research team at ursula.catena@policlinicogemelli.it for enrollment information.
Where is the NCT07077876 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07077876 clinical trial?
NCT07077876 is sponsored by Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The principal investigator is Ursula Catena at Fondazione Policlinico Universitario Agostino Gemelli IRCCS. The trial plans to enroll 100 participants.