Prognostic Role of molEcular classiFication in Fertility-sparing treAtment of Endometrial canCEr

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorFondazione IRCCS Istituto Nazionale dei Tumori, Milano

About this trial

Endometrial cancer, the most common gynecologic malignancy in high-income countries, is increasing among reproductive-age women. While hysterectomy prevents pregnancy, hormonal therapies offer fertility-sparing options for select early-stage cases, with \~80% achieving complete response (CR). Molecular classifications (POLEmut, p53abn, MMRd/MSI-H, NSMP) reveal subtype-specific prognostic differences, with NSMP showing higher CR rates and lower recurrence, while p53abn and MMRd/MSI-H fare worse. Recent studies emphasize molecular profiling's potential to guide personalized fertility-sparing treatments. This study explores the prognostic role of these classifications in treatment outcomes.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients aged 18-45 years with a hysteroscopic confirmed diagnosis of endometrial cancer (FIGO stage IA without myometrial invasion, grade 1 or grade 2, endometrioid histology).

Patients desiring fertility preservation

Molecular classification of the tumor using next-generation sequencing (NGS) or Proactive Molecular Risk Classifier for Endometrial Cancer (ProMisE).

Adequate pre-treatment imaging (MRI or transvaginal ultrasound) confirming no evidence of myometrial invasion or extrauterine spread.

Disqualifiers

Patients with atypical endometrial hyperplasia or intraepithelial neoplasia

Individuals with tumor samples of insufficient quantity or inadequate quality were not included in the analysis

Non-endometrioid histology.

Patients with a history of prior uterine malignancy or current synchronous malignancies.

Trial population

This is a prospective study enrolling patients with endometrial cancer eligible for fertility-sparing treatment. Data of consecutive patients treated from the 21st of January 2025.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Observation only

    Other intervention

    Only observation following standard of care (histological diagnosis, molecular classification, progestine therapy)

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Patients with endometrial cancer eligible for fertility-sparing treatment1 intervention

Trial outcomes

Primary outcomes

1

Response to fertility sparing treatmetn

To assess the differences in Complete Response (CR), Partial response/stable disease (PR/SD) and progression disease (PD) rates among molecular subtypes (NSMP, POLEmut, p53abn, MMRd/MSI-H) of endometrial cancer in patients undergoing fertility-sparing treatment.

Time frame
12 months
2

Recurrence

To evaluate the recurrence rates of endometrial cancer among these molecular subtypes following fertility-sparing treatment after a CR

Time frame
12 months

Secondary outcomes

1

Time to CR response

The number of months elapsed from the start of therapy to achieving a complete response.

Time frame
12 months
2

Obstetric outcomes

After fertility-sparing treatment, we assess outcomes such as pregnancy rate (percentage of individuals achieving pregnancy) and live birth rate (percentage of pregnancies resulting in a live baby) for the cohort.

Time frame
12 mesi

Other outcomes

Sponsors and contacts

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