Clinical trial · Observational
Surgical and Obstetric Outcomes in Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia With Conservative Treatment
Surgical and Obstetric Outcomes in Patients With Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia Undergoing Conservative Treatment
NCT07077876CI-TRIAL-00092445CHOICErecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Conservative Treatment Therapy | — | UNRESOLVED | — |
| Endometrial Adenocarcinoma | Endometrial Adenocarcinoma | CURATED_BROADER | 0.80 |
| Endometrial Hyperplasia | — | UNRESOLVED | — |
| Fertility Preservation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hysteroscopic Resection and Hormonal Therapy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Conservatively Treated Patients
- description
- Conservatively Treated Patients with Endometrial Cancer and Atypical Endometrial Hyperplasia
- interventionNames
- Procedure: Hysteroscopic Resection and Hormonal Therapy
Primary outcomes (3)
- measure
- Pregnancy Rate
- timeFrame
- Within 12 months from histologically confirmed complete response
- description
- Proportion of participants who achieve a clinical pregnancy (intrauterine gestational sac with fetal heartbeat) after conservative treatment.
- measure
- Miscarriage Rate
- timeFrame
- Within 12 months from histologically confirmed complete response
- description
- Proportion of pregnancies that end in miscarriage (pregnancy loss \< 20 weeks' gestation) among women who became pregnant after treatment.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDCatena U, Mirandola M, Capomacchia FM, Fanfani F, Scambia G. A new surgical approach for fertility-sparing management of diffuse endometrial G2 endometrioid adenocarcinoma: a step-by-step technique. Facts Views Vis Obgyn. 2023 Mar;15(1):79-81. doi: 10.52054/FVVO.15.1.058. PMID 37010338
- BACKGROUNDMorice P, Leary A, Creutzberg C, Abu-Rustum N, Darai E. Endometrial cancer. Lancet. 2016 Mar 12;387(10023):1094-1108. doi: 10.1016/S0140-6736(15)00130-0. Epub 2015 Sep 6. PMID 26354523
- BACKGROUNDJeon YT, Park IA, Kim YB, Kim JW, Park NH, Kang SB, Lee HP, Song YS. Steroid receptor expressions in endometrial cancer: clinical significance and epidemiological implication. Cancer Lett. 2006 Aug 8;239(2):198-204. doi: 10.1016/j.canlet.2005.08.001. Epub 2005 Sep 15. PMID 16168561
- BACKGROUNDDi Spiezio Sardo A, De Angelis MC, Della Corte L, Carugno J, Zizolfi B, Guadagno E, Gencarelli A, Cecchi E, Simoncini T, Bifulco G, Zullo F, Insabato L. Should endometrial biopsy under direct hysteroscopic visualization using the grasp technique become the new gold standard for the preoperative evaluation of the patient with endometrial cancer? Gynecol Oncol. 2020 Aug;158(2):347-353. doi: 10.1016/j.ygyno.2020.05.012. Epub 2020 May 25. PMID 32467056
- BACKGROUNDSung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4. PMID 33538338