NCT07838207 Prognosis and Therapeutic Implications in Molecular High-Risk Non-Myoinvasive Endometrial Cancer
| NCT ID | NCT07838207 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospital Universitari Vall d'Hebron Research Institute |
| Condition | Endometrial Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 350 participants |
| Start Date | 2026-05-01 |
| Primary Completion | 2026-11-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 350 participants in total. It began in 2026-05-01 with a primary completion date of 2026-11-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: 1. Patients over 18 years old. 2. 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: * 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). 3. 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. 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: 1. Molecular profile not available. 2. Absence of nodal staging (sentinel lymph node biopsy or lymphadenectomy) 3. Inadequate follow-up. 4. Mismatch repair-deficient tumors. 5. POLE-ultramutated tumors, when identified. 6. Incomplete information regarding adjuvant treatment. 7. Presence of myometrial invasion.
Contact & Investigator
Ana A Luzarraga Aznar, MD PhD
STUDY CHAIR
Hospital Universitari Vall d'Hebron Research Institute
Frequently Asked Questions
Who can join the NCT07838207 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Endometrial Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07838207 currently recruiting?
Yes, NCT07838207 is actively recruiting participants. Contact the research team at ana.luzarraga@vallhebron.cat for enrollment information.
Where is the NCT07838207 trial being conducted?
This trial is being conducted at Barcelona, Spain.
Who is sponsoring the NCT07838207 clinical trial?
NCT07838207 is sponsored by Hospital Universitari Vall d'Hebron Research Institute. The principal investigator is Ana A Luzarraga Aznar, MD PhD at Hospital Universitari Vall d'Hebron Research Institute. The trial plans to enroll 350 participants.
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