Идёт набор NCT07062016

Molecular and ctDNA Characterization of High-Risk Endometrial Cancer

— Наблюдательное Endometrial Carcinoma Endometrial High Grade Endometrioid Adenocarcinoma Stage II Endometrial Cancer Stage III Endometrial Cancer

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Non-Interventional Study.
Кому может быть актуально: Состояния в реестре: Endometrial Carcinoma, Endometrial High Grade Endometrioid Adenocarcinoma, Stage II Endometrial Cancer, Stage III Endometrial Cancer. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

MC230601 Molecular and ctDNA Characterization of High-Risk Endometrial Cancer

Обзор

This study seeks to better understand the recurrence of high-risk endometrial cancer. It will collect information about cancer genetics to find out various hereditary or cancer specific genetic variants that may have a role in diagnosis or management and prognosis of cancer. It also seeks to develop a genetic results and medical record databank for future studies.

Подробное описание

PRIMARY OBJECTIVE:

I. To generate preliminary data for a risk stratification model for recurrence including traditional histopathologic risk factors, molecular characterization in endometrial cancer patients with features of aggressive disease.

OUTLINE: This is an observational study.

Patients undergo blood and tissue sample collection and have their medical records reviewed throughout the study.

Вмешательства

Другое Non-Interventional Study
Non-interventional study

Первичные конечные точки

Recurrence-free survival (RFS) [Срок оценки: Up to 3 years]
Presence of somatic and germline pathogenic variants [Срок оценки: Up to 3 years]

Критерии участия

Критерии включения

Age ≥ 18 years
Planned complete surgical staging at Mayo Clinic. Complete surgical staging includes at least total hysterectomy, bilateral salpingo-oophorectomy and lymph node assessment. Sentinel node mapping meets the criteria for lymph node assessment. Peritoneal cytology is recommended. Additional staging procedures such as pelvic and para-aortic nodal evaluation, omental biopsy or omentectomy, may also be utilized for staging in patients based on the clinical situation and at the surgeon's discretion
At least one preoperative or postoperative feature of aggressive disease \[International Federation of Gynecology and Obstetrics (FIGO) staging used throughout this protocol\]

Preoperatively:

Biopsy with grade 3 endometrioid endometrial cancer (EC) or non-endometrioid EC
Patients with FIGO grade 1-2 EC with evidence of extrauterine disease on imaging (CT, MRI, or PET)
Postoperatively:

Endometrial cancer (FIGO) with one or more established risk factors:

Non-endometrioid histology

Grade 3
Lymphovascular space invasion (LVSI), ≥ 50% of myometrial invasion, presence of isolated tumor cells (ITC) in a sentinel lymph node OR
Stage II to IV (FIGO) EC
Provide written informed consent
Willingness to provide mandatory blood specimens for correlative research
Willingness to provide mandatory tissue specimens for correlative research
Willingness to return to registering site for clinical follow-up