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Идёт набор NCT07186296

EXoPERT EMERALD Clinical Study

— Наблюдательное Breast Cancer Colon Cancer Pancreatic Cancer 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: EXoPred.
Кому может быть актуально
Состояния в реестре: Breast Cancer, Colon Cancer, Pancreatic Cancer, Ovarian Cancer. Базовые параметры: от 45 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
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

EXoPERT EMERALD: Early Multi-cancer Study of EV's Ramen-AL Linked Diagnosis Clinical Study Protocol

Обзор

The purpose of this study is to establish a multi-center clinical repository of blood samples to support the development and evaluation of an artificial intelligence-based in vitro diagnostic software. The software analyzes surface-enhanced Raman spectroscopy (SERS) profiles of extracellular vesicles (EVs) extracted from human plasma for the early detection of multiple cancers, including lung, ovarian, breast, pancreatic, and colorectal cancers.

Подробное описание

The EMERALD study is a multi-center study (Protocol No. EXPT-MC-F-2024) designed to establish a clinical plasma repository for the training and clinical evaluation of the ExoPred deep learning software

The study protocol operates in three sequential phases to ensure data integrity and prevent algorithmic overfitting:

Phase 1 (Algorithm Training Stage): A minimum of 500 samples are analyzed to develop the algorithm and establish the initial clinical cut-off values, followed by a database lock.

Phase 2 (Algorithm Lock-Readiness Assessment): A minimum of 50 newly acquired unknown samples are evaluated to assess model robustness before the final algorithm is formally locked in the Technical File.

Phase 3 (Blinded Independent Stage): A minimum of 200 independent samples, strictly excluded from prior phases, are tested under strict blinding to evaluate finalized clinical sensitivity, specificity, and accuracy.

The locked software analyzes surface-enhanced Raman spectroscopy (SERS) profiles of extracellular vesicles (EVs) to detect five target malignancies: lung, breast, colorectal, pancreatic, and ovarian cancers. Based on multi-class classification probability scoring, the predicted tissue of origin (TOO) can be presented for up to a maximum of three cancer types. All data handling and automated quality checks follow standard operating procedures (SOPs) within a 21 CFR Part 11 compliant EDC system.

Вмешательства

  • Диагностический тест EXoPred
    Performing invitro Diagnostics with devices developed by EXoPERT.

Первичные конечные точки

  • Test Sufficient Samples [Срок оценки: From date of enrollment up to 36 months]
  • Evaluate Performance [Срок оценки: From date of enrollment up to 36 months]

Критерии участия

Критерии включения

  • Subject aged 45 years or older with a biopsy-proven or clinically suspected primary lung, breast, colorectal, pancreatic, or ovarian cancer, based on objective findings such as radiological, serological, endoscopic, or cytological findings, whose blood was collected prior to any systemic or definitive therapy for the cancer.
  • Subjects who are willing and able to provide written informed consent.
  • Subjects who are willing and able to comply with the study requirements.

Критерии исключения

  • Any history of cancer diagnosed and treated within 5 years prior to the date of consent.
  • Subjects with a history of previous cancer treatment via surgical resection, hormonal cancer treatment, chemotherapy, radiotherapy within the past 6 months for recent cancer diagnosis.
  • Subjects who have any history of an allogeneic bone marrow, stem cell transplant, or solid organ transplant.
  • Subjects who are pregnant or breastfeeding women.
  • Subjects who have consented and have undergone treatment in any other cancer related clinical trials withinthe past 6 months.
  • Subjects who are currently in active treatment for drug abuse.
  • Subjects who have received any treatment related to lung, breast, colorectal, pancreatic, or ovarian nodules, such as hormones prior to entering the study.
  • Unsuitable sample for testing due to contamination, hemolysis, etc.

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

Здоровые добровольцы: Да

Дизайн исследования

Модель наблюдения
Случай-контроль

Центры проведения

США · 9 центров
  • Tibor Rubin VA Medical Center — Long Beach
  • City of Hope Duarte Cancer Center — Los Angeles
  • University of Hawaii Cancer Center — Honolulu
  • Lexington VA Healthcare System — Lexington
  • KCTL — Louisville
  • John Hopkins University — Baltimore
  • Albany Stratton VA Medical Center — Albany
  • Bronx Veterans Medical Research Foundation — The Bronx
  • … и ещё 1 центр

Идентификаторы

NCT: NCT07186296 · EXPT-MC-F-2024

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗