A Prospective Registry Study in Patients With Unresectable Locally Advanced or Metastatic Breast Cancer (MBC)
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: No intervention.
- Кому может быть актуально
- Состояния в реестре: Breast Neoplasms. Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Испания
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
This study is a prospective, multicenter non-interventional cohort study designed to develop a registry in unresectable locally advanced or metastatic disease.
Подробное описание
The target population for inclusion in this study is breast cancer patients recently diagnosed (from January 2016) with unresectable locally advanced or metastatic disease (either after a recurrence or as first diagnosis). No treatment regimen will be protocol specified. This is an observational study in which clinical decisions concerning the optimum management strategy for a particular patient are taken independently of and/or prior to, any decision by the physician to invite a patient to participate in the study. The treating physician will make all treatment decisions according to his/her regular clinical practice independent of this study. Patients enrolled on the study are free to withdraw their informed consent for the use and disclosure of health information at any time and when asked, patients are not obliged to provide a reason. Patients may request discontinuation from the study at any time.
The date and the reason for withdrawal or discontinuation from the study must be recorded in the electronic case report form (eCRF). An attempt will be made to determine the date of discontinuation and final status (i. e. withdrawal of consent, loss to follow-up, death) of any patient who discontinues from the study. However, the treating clinician is encouraged to follow the patient as long as possible, until patient death or through study end. The Sponsor has the right to terminate the study at any time. The Sponsor will notify the investigator if the study is placed on hold or if the Sponsor decides to discontinue the study.
Вмешательства
- Другое No intervention
Первичные конечные точки
- Number of patients with the different breast cancer subtypes and real distribution of them. [Срок оценки: 8 years]
Вторичные конечные точки (4)
- Patient and tumor characteristics and frequency of breast cancer with heredofamiliar risk. [Срок оценки: 8 years]
- Differences in the development disease in the group of male vs female patients. [Срок оценки: 8 years]
- Influence of timing of primary tumor surgery in patients with metastatic disease as first diagnosis [Срок оценки: 8 years]
- Number of participants with specific biomarkers on tumor and blood samples. [Срок оценки: 8 years]
Критерии участия
Критерии включения
- Patients (males or females) diagnosed with unresectable locally advanced or MBC (either after a recurrence or as first diagnosis) from January 2016 onwards.
- Patients who died are allowed to be included on the study.
- Able and willing to provide written informed consent if they are alive.
- Age ≥ 18 years.
- Availability to medical records access and all data related to the disease management.
Критерии исключения
None
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Испания · 40 центров
- Hospital General de Elche — Elche
- Althaia-Xarxa Assistencial de Manresa — Manresa
- Consorci Sanitari de Terrassa — Terrassa
- Hospital Universitario Donostia — San Sebastián
- Hospital Dr. Negrín — Las Palmas de Gran Canaria
- Hospital Universitario Fundación Alcorcón — Alcorcón
- Hospital Universitario de Fuenlabrada — Fuenlabrada
- Hospital Universitario Severo Ochoa — Leganés
- … и ещё 32 центра
Идентификаторы
NCT: NCT02819882 · GEICAM 2014-03