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OncoMatch/Clinical Trials/NCT07838207

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

Official title: MyoNone: Prognosis and Therapeutic Implications in Molecular High-Risk Non-Myoinvasive Endometrial Cancer

Is NCT07838207 recruiting? Yes, currently enrolling (Oct 2026).

RecruitingHospital Universitari Vall d'Hebron Research InstituteNCT07838207Data as of Oct 2026Location: Spain

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.

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Extracted eligibility criteria

Cancer type

Endometrial Cancer

Biomarker criteria

Required: TP53 abnormal

p53-abnormal (p53-abn) endometrial carcinoma

Required: ESR1 expression (absence)

ER-negative NSMP tumours

Excluded: POLE ultramutated

POLE-ultramutated tumors, when identified

Excluded: MLH1 loss

Mismatch repair-deficient tumors

Excluded: MSH2 loss

Mismatch repair-deficient tumors

Excluded: MSH6 loss

Mismatch repair-deficient tumors

Excluded: PMS2 loss

Mismatch repair-deficient tumors

Disease stage

Required: Stage IC (other)

Excluded: Stage IIIC

Grade: high-grade

only patients with a final stage IC (FIGO 2023) will be included; Stage IIIC tumours will not be excluded; cases will be selected based on the absence of myometrial infiltration in the final pathology specimen

Demographics

Female only

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07838207 currently recruiting?

Yes, this trial is currently recruiting patients.

Does this trial require TP53?

Yes, TP53 abnormal is a required biomarker for enrollment.

Does this trial require ESR1?

Yes, ESR1 expression is a required biomarker for enrollment.

Are patients with POLE alterations eligible?

No. POLE ultramutated is an exclusion criterion.

Are patients with MLH1 alterations eligible?

No. MLH1 loss is an exclusion criterion.

What disease stage is eligible?

Stage IC is required.

Is this trial open to male patients?

No. This trial enrolls female patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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