Hospital Universitari Vall d'Hebron
Barcelona, 08028, Spain
Location status: Recruiting
NCT Number: NCT07838207
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.
Interested in participating?
Request Info18 year and older
Female
Observational
Barcelona, 08028, Spain
Location status: Recruiting
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
2.1. p53-abnormal (p53-abn) endometrial carcinoma. 2.2. ER-negative NSMP tumours. 2.3. High-grade NSMP tumours. POLE mutations assessment is not mandatory. MMR and p53 status is mandatory, according to ESGO criteria.
In whom:
3.1. To assess the rate of lymph node involvement, we will analyze tumors with the previous molecular characteristics mentioned and no myometrial invasion, regardless of whether lymph node involvement is present. Stage IIIC tumours will not be excluded; cases will be selected based on the absence of myometrial infiltration in the final pathology specimen. 3.2. On the other hand, for the survival statistical analyses, only patients with a final stage IC (FIGO 2023) will be included.
Exclusion criteria
Patients who do not meet the above inclusion criteria and who additionally present with the following conditions will be excluded:
Time frame: At primary surgery
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: Up to 10 years
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
In patients with p53abn tumours, ER-negative NSMP tumours, or high-grade NSMP tumours without myometrial invasion
Time frame: Up to 10 years
In patients with p53abn tumours, ER-negative NSMP tumours, or high-grade NSMP tumours without myometrial invasion
Time frame: Up to 10 years
OS according to adjuvant treatment received in patients with p53abn tumours, ER-negative NSMP tumours, or high-grade NSMP tumours without myometrial invasion, comparing:
Time frame: Up to 10 years
PFS according to adjuvant treatment received in patients with p53abn tumours, ER-negative NSMP tumours, or high-grade NSMP tumours without myometrial invasion, comparing:
Interested in participating?
Request InfoHospital Universitari Vall d'Hebron Research Institute
Other
MyoNone: Prognosis and Therapeutic Implications in Molecular High-Risk Non-Myoinvasive Endometrial Cancer
Acronym: MyoNone
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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