通过将基因组分析新技术与手术子宫外疾病评估（EUGENIE）相结合来改善子宫内膜癌评估。
Improving Endometrial cancer assessment by combining the new techniqUe of GENomic profiling with surgical Extra uterIne disEase assessment (EUGENIE).
作者信息
Kasius Jenneke C, Trozzi Rita, Pijnenborg Johanna, Baert Thaïs, Laenen Annouschka, Van Rompuy Anne-Sophie, Zapardiel Ignacio, Vizzielli Giuseppe, Knez Jure, Fanfani Francesco, Amant Frédéric
机构信息
Department of Gynecological Oncology, Amsterdam University Medical Centres, Centre for Gynecological Oncology Amsterdam (CGOA), 22660 1100 DD, Amsterdam, The Netherlands.
Department of Women, Children and Public Health Sciences, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Rome, Italy.
出版信息
Int J Gynecol Cancer. 2023 May 1;33(5):823-826. doi: 10.1136/ijgc-2023-004289.
BACKGROUND
The molecular classification of endometrial cancer revolutionized our knowledge of its biology but so far has not affected our surgical approach. The exact risk of extra-uterine metastasis and hence the type of surgical staging for each of the four molecular subgroups are currently unknown.
PRIMARY OBJECTIVE
To determine the association between molecular classification and disease stage.
STUDY HYPOTHESIS
Each endometrial cancer molecular subgroup has a specific pattern of spread and this pattern of spread could guide the extent of surgical staging.
TRIAL DESIGN
Prospective, multicenter study MAJOR INCLUSION/EXCLUSION CRITERIA: Participants eligible for inclusion in this study must meet all the following criteria: women ≥18 years with primary endometrial cancer, any histology and stage.
PRIMARY ENDPOINT
Number and site of metastasis in each endometrial cancer molecular subgroup.
SAMPLE SIZE
1000 patients will be enrolled.
ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS
The trial will last 6 years: 4 years of accrual, and 2 years of follow-up of all patients. Results on staging and oncological outcomes are expected in 2027 and 2029, respectively.
TRIAL REGISTRATION
The study has been accepted by UZ Leuven Ethical Committee. Belg. Reg. nr: B3222022000997.
背景
子宫内膜癌的分子分类彻底改变了我们对其生物学特性的认识，但迄今为止尚未影响到我们的手术方式。目前尚不清楚子宫外转移的确切风险，以及四个分子亚组中每个亚组的手术分期类型。
主要目的
确定分子分类与疾病分期之间的关联。
研究假设
每个子宫内膜癌分子亚组都有特定的扩散模式，这种扩散模式可指导手术分期的范围。
试验设计
前瞻性多中心研究
主要纳入/排除标准：符合本研究纳入条件的参与者必须满足以下所有标准：年龄≥18岁的原发性子宫内膜癌女性，任何组织学类型和分期。
主要终点
每个子宫内膜癌分子亚组中转移的数量和部位。
样本量
将招募1000名患者。
预计完成入组和公布结果的日期
该试验将持续6年：4年入组，所有患者随访2年。预计分别于2027年和2029年公布分期和肿瘤学结局的结果。
试验注册
该研究已获得鲁汶大学伦理委员会批准。比利时注册号：B3222022000997。
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