An observational study in Endometrial Cancer, Endometrial Carcinoma (EC) and p53abn, sponsored by Hospital Universitari Vall d'Hebron Research Institute. Recruiting at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Hospital Universitari Vall d'Hebron Research Institute · Observational
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:
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.
1,425 studies on the registry are indexed under Endometrial Neoplasms; 473 are open to participants now.
This study's planned enrollment of 350 is above the median of 179 across 331 observational studies indexed under Endometrial Neoplasms.
Browse Endometrial Neoplasms studies →Hospital Universitari Vall d'Hebron Research Institute is the lead sponsor of 276 studies on the registry; 64 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with EC between 2010 and 2025 with:
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Patients with:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
PFS according to adjuvant treatment
PFS 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
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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