MyoNone: Prognosis and Therapeutic Implications in Molecular High-Risk Non-Myoinvasive Endometrial Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Rate of lymph node involvement
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients over 18 years old.
- •Patients with:
- •p53-abnormal (p53-abn) endometrial carcinoma. 2.
- •ER-negative NSMP tumours. 2.
- •High-grade NSMP tumours. POLE mutations assessment is not mandatory. MMR and p53 status is mandatory, according to ESGO criteria.
- •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.
- •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.
- •On the other hand, for the survival statistical analyses, only patients with a final stage IC (FIGO 2023) will be included.
排除标准
- •Patients who do not meet the above inclusion criteria and who additionally present with the following conditions will be excluded:
- •Molecular profile not available.
- •Absence of nodal staging (sentinel lymph node biopsy or lymphadenectomy)
- •Inadequate follow-up.
- •Mismatch repair-deficient tumors.
- •POLE-ultramutated tumors, when identified.
- •Incomplete information regarding adjuvant treatment.
- •Presence of myometrial invasion.
研究组 & 干预措施
p53-abnormal tumours without myometrial invasion
High-grade NSMP tumours without myometrial invasion.
ER-negative NSMP tumours without myometrial invasion.
结局指标
主要结局
Rate of lymph node involvement
时间窗: 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.
次要结局
- Pattern of recurrence(Up to 10 years)
- Progression-free survival (PFS)(Up to 10 years)
- Overall survival (OS)(Up to 10 years)
- OS according to adjuvant treatment(Up to 10 years)
- PFS according to adjuvant treatment(Up to 10 years)