Идёт набор NCT05129969

Registry Platform Ovarian and Endometrial Cancer

— Наблюдательное Ovarian Cancer Endometrial Cancer Ovary Neoplasm Endometrial Neoplasms

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: Physician's choice according to patient's needs..
Кому может быть актуально: Состояния в реестре: Ovarian Cancer, Endometrial Cancer, Ovary Neoplasm, Endometrial Neoplasms. 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: Германия
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

SMARAGD - Clinical Research Platform on Ovarian, Fallopian Tube, Primary Peritoneal and Endometrial Cancer Treatment and Outcomes

Обзор

The purpose of the project is to set up a national, prospective, longitudinal, multicenter cohort study, a tumor registry platform, to document uniform data on characteristics, molecular diagnostics, treatment and course of disease, to collect patient-reported outcomes and to establish a decentralized biobank for patients with advanced or metastatic ovarian cancer (OC) or advanced or metastatic endometrial cancer (EC) in Germany.

Подробное описание

SMARAGD is a national, prospective, open-label, longitudinal, non-interventional multicenter cohort study (tumour registry platform) to describe treatment in routine clinical practice of ovarian, fallopian tube, primary peritoneal and endometrial patients in routine care in Germany.

The registry will follow patients for up to three years with the aim to identify common therapeutic sequences and changes in the treatment of the disease. At inclusion, data in patient characteristics, comorbidities, tumor characteristics and previous treatments are collected. During the course of observation data on all systemic treatments, radiotherapies, surgeries, and outcome are documented.

Health-related quality of life (HRQoL) will be evaluated for up to three years.

Вмешательства

Другое Physician's choice according to patient's needs.
Routine care as per site standard.

Первичные конечные точки

Course of treatment (treatment reality). [Срок оценки: 3 years per patient]

Вторичные конечные точки (5)

Best Response. [Срок оценки: 3 years per patient]
Progression-free survival. [Срок оценки: 3 years per patient]
Overall survival. [Срок оценки: 3 years per patient]
Health-related quality of life (Patient-reported outcome, PRO). [Срок оценки: 3 years per patient]
Health-related quality of life (Patient-reported outcome, PRO). [Срок оценки: 3 years per patient]

Критерии участия

Критерии включения

Confirmed high grade OC (advanced or metastatic epithelial ovarian, fallopian tube and primary peritoneal cancer):

patients with FIGO stage IIb-IV OC who are starting systemic treatment or
patients with recurrent/relapsed disease, who received any previous systemic anti-tumor treatment and who are now starting systemic treatment for recurrent/relapsed disease.
Locally advanced and inoperable or metastatic EC (FIGO stage III-IV) who are starting systemic first-line therapy.
Signed and dated informed consent (IC):

Patients participating in PRO module: IC before first therapy cycle
Patients not participating in PRO module: IC no later than six weeks after start of first therapy cycle