About this trial
This multicenter retrospective observational cohort study aims to evaluate the prognosis of patients with non-myoinvasive endometrial cancer harbouring high-risk molecular features by determining the rate of lymph node involvement (assessed by sentinel lymph node biopsy and/or lymphadenectomy), evaluating recurrence rates, progression-free survival (PFS) and overall survival (OS), and comparing oncological outcomes according to different adjuvant treatments.
The study will include patients with the following molecular subgroups of non-myoinvasive endometrial cancer:
* p53-abnormal tumours without myometrial invasion. * High-grade NSMP tumours without myometrial invasion. * ER-negative NSMP tumours without myometrial invasion.
Participating centres will be invited to retrospectively identify eligible patients diagnosed between 2010 and 2025 and enter anonymised data into a standardised REDCap database. Given the rarity of these clinical scenarios, international collaboration is essential to generate robust evidence that may help inform future clinical guidelines and optimize patient management.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients over 18 years old.
No myometrial invasion is present in the final surgical specimen (nor cervical or adnexal invasion).
Tumours are identified by endometrial biopsy or hysteroscopic polypectomy with no residual tumour in the final surgical specimen (these cases will also be considered tumours without myometrial invasion).
Patients who underwent nodal staging, either with pelvic sentinel lymph node biopsy, associated with pelvic and/or para-aortic lymphadenectomy, or staged by lymphadenectomy alone.
Disqualifiers
Molecular profile not available.
Absence of nodal staging (sentinel lymph node biopsy or lymphadenectomy)
Inadequate follow-up.
Mismatch repair-deficient tumors.
Trial population
Patients diagnosed with EC between 2010 and 2025 with: * p53-abnormal (p53-abn) endometrial cancer without myometrial invasion * ER-negative NSMP tumours without myometrial invasion * High-grade NSMP tumours without myometrial invasion
Trial design
Cohort
Retrospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Rate of lymph node involvement
Assessed by sentinel lymph node biopsy and/or lymphadenectomy in patients with p53abn tumours, ER-negative NSMP tumours, or high-grade NSMP tumours without myometrial invasion.
Secondary outcomes
Pattern of recurrence
Number and anatomical location of recurrence in patients with p53abn tumours, ER-negative NSMP tumours, or high-grade NSMP tumours without myometrial invasion
Progression-free survival (PFS)
In patients with p53abn tumours, ER-negative NSMP tumours, or high-grade NSMP tumours without myometrial invasion
Overall survival (OS)
In patients with p53abn tumours, ER-negative NSMP tumours, or high-grade NSMP tumours without myometrial invasion
OS according to adjuvant treatment
OS according to adjuvant treatment received in patients with p53abn tumours, ER-negative NSMP tumours, or high-grade NSMP tumours without myometrial invasion, comparing: * No adjuvant treatment * Radiotherapy or brachytherapy * Chemotherapy ± radiotherapy or brachytherapy.
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