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Идёт набор NCT07491081

EARLY Study: Evaluating the Specificity and Feasibility of the EARLY Biomarker Panel for Ovarian Cancer Detection

Без фазы С лечением Ovarian 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: Intervention 1, Intervention 2.
Кому может быть актуально
Состояния в реестре: Ovarian Cancer. Базовые параметры: 50 лет — 74 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
Австралия
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Обзор

The overall aim of the EARLY study is to systematically evaluate the impact of blood collection protocols, storage temperatures, transport conditions, and time to processing on the stability of extracellular vesicle (EV) biomarkers associated with ovarian cancer, with the potential to inform and improve future ovarian cancer screening practices. This prospective study will inform future screening studies by: 1. Assessing the feasibility of participant recruitment and blood sample collection for extracellular vesicle analysis in a real-world healthcare setting, including evaluation of the practicality and effectiveness of these processes. 2. Evaluating the stability of collected and transported blood samples and isolated extracellular vesicles during shipment and storage. A total of 1,500 participants will be recruited through community groups across Queensland, Australia, in collaboration with the Mater Research Biobank. Eligible participants who provide informed consent will have approximately 30 mL of blood collected for extracellular vesicle analysis. Data will also be collected on demographics (e.g. age and ethnicity), lifestyle factors (e.g. smoking status), medical, surgical and gynaecological history, family history of cancer, date of last menstrual period, and use of hormone replacement therapy (HRT). Participation in the study will conclude after blood sample collection.

Вмешательства

  • Другое Intervention 1
    Approximately 30 mL of peripheral venous blood will be collected from each participant using validated blood collection tubes. Samples will be processed according to predefined standard operating procedures, including controlled storage temperatures and defined time-to-processing conditions.
  • Другое Intervention 2
    Collected blood samples and derived extracellular vesicles will be exposed to different pre-analytical conditions including: * Variation in storage temperatures * Variation in transport conditions * Variation in time from collection to processing * Evaluation of extracellular vesicle stability during shipment and storage

Первичные конечные точки

  • Proportion of participants with successful blood collection and extracellular vesicle extraction according to the study protocol (feasibility). [Срок оценки: 5 years]
  • Proportion of eligible participants who provide informed consent to participate in the study among all individuals approached and assessed for eligibility (acceptability). [Срок оценки: 5 years]
  • Effect of real-world sampling and processing methods on extracellular vesicle particle concentration (particles/mL) measured by nanoparticle tracking analysis (NTA) (quality). [Срок оценки: 5 years]
  • Effect of real-world sampling and processing methods on EV size distribution (mean and mode, nm) measured by nanoparticle tracking analysis (NTA) (quality). [Срок оценки: 5 years]
  • Effect of real-world sampling and processing methods on EV biomarker expression assessed using EV-associated protein markers (quality). [Срок оценки: 5 years]

Критерии участия

Критерии включения

  • Age between 50 and 74 years (inclusive).
  • Postmenopausal status, defined as either:

2.1. At least 12 consecutive months of amenorrhoea following natural menopause or hysterectomy, or 2.2. At least 12 months of hormone replacement therapy (HRT) commenced for the management of menopausal symptoms.

  • Signed written informed consent.

Критерии исключения

  • History of previous ovarian malignancy.
  • History of bilateral oophorectomy.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Не применимо
Модель
Одна группа
Маскирование
Открытое
Основная цель
Другое

Центры проведения

Австралия · 2 центра
  • Mater Misericordiae Ltd — Brisbane
  • The University of Queensland — Brisbane

Идентификаторы

NCT: NCT07491081 · Early Study

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗