A new surgical approach for fertility-sparing management of diffuse endometrial G2 endometrioid adenocarcinoma: a step-by-step technique.
U Catena, M Mirandola, F M Capomacchia...
https://pubmed.ncbi.nlm.nih.gov/37010338Actively Recruiting
Age: 18Years +
FEMALE
ID07077876
Surgical and Obstetric Outcomes in Patients With Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia Undergoing Conservative Treatment
Led by Fondazione Policlinico Universitario Agostino Gemelli IRCCS · Updated on 2025-07-22
100
Participants Needed
1
Research Sites
29 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the obstetric and oncological outcomes in women diagnosed with endometrial adenocarcinoma (EAC) or atypical endometrial hyperplasia (AEH) who received conservative treatment. This observational, single-center study takes place at the CLASS Hysteroscopy Center in Rome and focuses on patients treated either to preserve fertility or due to medical reasons preventing standard radical surgery. The treatment involves hysteroscopic removal of lesions using a 15 Fr mini-resectoscope, sometimes combined with visual dilation and curettage techniques. After surgery, a 52 mg levonorgestrel-releasing intrauterine device (LNG-IUD) is placed. In certain cases, especially for patients with higher-grade cancer or poor prognostic markers, oral progestin therapy with Megestrol Acetate is added. Follow-up includes hysteroscopic biopsies at 3, 6, and 12 months. Participants will be monitored for pregnancy rates, miscarriage rates, and live birth rates within 12 months following a confirmed complete response. Researchers will also assess the disease-free interval for up to 12 months after treatment. The total follow-up lasts one year, with periodic biopsies to evaluate treatment response and ongoing health.
CONDITIONS
Brief Title
Surgical and Obstetric Outcomes in Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia With Conservative Treatment
Who Can Participate
Age: 18Years +
FEMALE
Eligibility Criteria
You may qualify if you...
- Female patients aged 18 years or older
- Histological diagnosis of endometrial adenocarcinoma (EAC) or atypical endometrial hyperplasia (AEH)
- Conservative treatment with hysteroscopic resection at the CLASS Hysteroscopy Center by a single experienced surgeon
- Treatment due to medical contraindications to radical surgery
- Signed informed consent for participation in the study
You will not qualify if you...
- Patients with other known causes of infertility
- Non-endometrioid histological subtypes of endometrial adenocarcinoma
- Patients under 18 years of age
- Patients who did not provide informed consent for participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Surgery and Immediate Post-operative Care
Duration - Single procedure with immediate post-operative care
Participants undergo hysteroscopic resection of the endometrial lesion and insertion of a levonorgestrel-releasing intrauterine device (LNG-IUD). Some participants may also receive oral progestin therapy with Megestrol Acetate depending on their condition.
1 visit (in-person) for the procedure
Post-operative Follow-up
Duration - Up to 12 months
Participants are monitored with hysteroscopic endometrial biopsies to assess treatment response and disease status.
Visits at 3, 6, and 12 months (in-person)
Trial Site Locations
Total: 1 location
1
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
Actively Recruiting
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Research Team
U
URSULA CATENA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Endometrial cancer.
Philippe Morice, Alexandra Leary, Carien Creutzberg...
https://pubmed.ncbi.nlm.nih.gov/26354523Steroid receptor expressions in endometrial cancer: clinical significance and epidemiological implication.
Yong-Tark Jeon, In-Ae Park, Yong-Beom Kim...
https://pubmed.ncbi.nlm.nih.gov/16168561Should 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?
Attilio Di Spiezio Sardo, Maria Chiara De Angelis, Luigi Della Corte...
https://pubmed.ncbi.nlm.nih.gov/32467056Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries.
Hyuna Sung, Jacques Ferlay, Rebecca L Siegel...
https://pubmed.ncbi.nlm.nih.gov/33538338