Prognosis and Therapeutic Implications in Molecular High-Risk Non-Myoinvasive Endometrial Cancer

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18+
SponsorHospital Universitari Vall d'Hebron Research Institute

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

Not listed

Trial groups

350 Participants
are grouped into 3 trial groups
Group A: p53-abnormal tumours without myometrial invasion
Group B: High-grade NSMP tumours without myometrial invasion.
Group C: ER-negative NSMP tumours without myometrial invasion.

Trial outcomes

Primary outcomes

1

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.

Time frame
At primary surgery

Secondary outcomes

1

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

Time frame
Up to 10 years
2

Progression-free survival (PFS)

In patients with p53abn tumours, ER-negative NSMP tumours, or high-grade NSMP tumours without myometrial invasion

Time frame
Up to 10 years
3

Overall survival (OS)

In patients with p53abn tumours, ER-negative NSMP tumours, or high-grade NSMP tumours without myometrial invasion

Time frame
Up to 10 years
4

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.

Time frame
Up to 10 years

Other outcomes

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