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Endometrial AdenocarcinomaCHOICENCT07077876

Surgical and Obstetric Outcomes in Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia With Conservative Treatment

An observational study of Endometrial Adenocarcinoma and Endometrial Hyperplasia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Hysteroscopic Resection and Hormonal Therapy
How many people
100 participants
Where
1 siteItaly
Study dates
20 Jun 2025to 20 Jan 2026
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Women diagnosed with early-stage endometrial adenocarcinoma (EAC) or atypical endometrial hyperplasia (AEH) who underwent conservative hysteroscopic treatment at the CLASS Hysteroscopy Center of Fondazione Policlinico Universitario A. Gemelli IRCCS, either for fertility preservation or due to contraindications to radical surgery. All procedures were performed by a single experienced surgeon.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

URSULA CATENA contact

+393382760021

ursula.catena@policlinicogemelli.it

Italy1 site, 1 recruiting

  • Fondazione Policlinico Universitario A. Gemelli IRCCS

    Roma

    URSULA CATENA, MD, +393382760021, ursula.catena@policlinicogemelli.it

    Recruiting

Other trials in Italy

About this study

Official title: Surgical and Obstetric Outcomes in Patients With Endometrial Adenocarcinoma and Atypical Endometrial Hyperplasia Undergoing Conservative Treatment

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.

Read the detailed description

This is a monocentric cohort study conducted at the CLASS Hysteroscopy Center of Fondazione Policlinico Universitario A. Gemelli IRCCS in Rome. It includes women diagnosed with endometrial adenocarcinoma (EAC) or atypical endometrial hyperplasia (AEH) who underwent conservative treatment using standardized hysteroscopic techniques performed by a single surgeon. The intervention consists of hysteroscopic lesion resection, insertion of a 52 mg levonorgestrel-releasing IUD, and in selected cases oral progestin therapy with Megestrol Acetate. The study includes both women desiring fertility preservation and patients medically unfit for radical surgery. Follow-up includes hysteroscopic biopsies at 3, 6, and 12 months. The primary objective is to assess obstetric outcomes, with secondary endpoints including oncologic outcomes.

Being tested
Hysteroscopic Resection and Hormonal Therapy
Keywords
Endometrial Cancer, Atypical Endometrial Hyperplasia, Fertility-Sparing Treatment, Hysteroscopy, Progestin Therapy, Reproductive Outcomes
Medical subject headings
Endometrial Hyperplasia, Endometrial Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Hysteroscopic Resection and Hormonal TherapyProcedure or surgery

    Patients underwent hysteroscopic resection of atypical endometrial hyperplasia (AEH) or grade 1-2 endometrial adenocarcinoma (EAC) using a 15 Fr mini-resectoscope. Depending on the case, the procedure included visual D\&C or a combined technique. At the end of the procedure, a 52 mg levonorgestrel-releasing intrauterine device (LNG-IUD) was inserted. In patients with EAC G2 or poor prognostic markers (e.g., MMR deficiency), oral progestin therapy with Megestrol Acetate (160 mg daily) was added. Follow-up included hysteroscopic endometrial biopsy at 3, 6, and 12 months to assess response.

Study groups in NCT07077876
Study groupRoleWhat they receive
Conservatively Treated PatientsConservatively Treated Patients with Endometrial Cancer and Atypical Endometrial Hyperplasia
Receives: Procedure: Hysteroscopic Resection and Hormonal Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pregnancy Rate

    Proportion of participants who achieve a clinical pregnancy (intrauterine gestational sac with fetal heartbeat) after conservative treatment.

    Measured: Within 12 months from histologically confirmed complete response

  2. Miscarriage Rate

    Proportion of pregnancies that end in miscarriage (pregnancy loss < 20 weeks' gestation) among women who became pregnant after treatment.

    Measured: Within 12 months from histologically confirmed complete response

  3. Live Birth Rate

    Proportion of pregnancies resulting in at least one live-born infant after treatment.

    Measured: Within 12 months from histologically confirmed complete response

Secondary outcomes (1)

  1. Disease-Free Interval

    Evaluation of time without disease recurrence from date of conservative treatment for EAC or AEH.

    Measured: Up to 12 months after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jul 2025
  2. Study start20 Jun 2025
  3. Primary completion30 Jun 2025
  4. Study completion20 Jan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07077876
Sponsor's protocol ID
7309
Acronym
CHOICE
Status last verified
Jul 2025
First submitted
26 Jun 2025
Last updated
22 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Catena 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.

    PubMed 37010338

  • Morice 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.

    PubMed 26354523

  • Jeon 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.

    PubMed 16168561

  • Di 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.

    PubMed 32467056

  • Sung 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.

    PubMed 33538338

Questions about this trial

What is this clinical trial studying?

An observational study of Endometrial Adenocarcinoma and Endometrial Hyperplasia, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact URSULA CATENA (+393382760021, ursula.catena@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pregnancy Rate (time frame: Within 12 months from histologically confirmed complete response). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07077876, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.

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