Exosomes in Rectal 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: Blood Draw.
- Кому может быть актуально
- Состояния в реестре: Rectal Cancer. 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
- 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
Exosomal as Correlative Biomarker in Clinical Outcomes in Patients Undergoing Neoadjuvant Chemoradiation Therapy for Rectal Cancer
Обзор
The primary aims of this study is to characterize exosomal biomarker levels in patients with locally advanced rectal cancer undergoing neoadjuvant chemoradiation therapy. Compare rates of exosomal expression before during and after chemoradiation therapy with pathologic response rates at the time of APR or LAR. The researchers will also examine the functionality of these exosomes in malignant colonic organoids and mouse models of colorectal cancer.
Подробное описание
All male and female patients, aged 18 and older with a histologically proven diagnosis of rectal adenocarcinoma, treated on this study will receive neo adjuvant chemotherapy (consisting of 5 FU or capecitabine) given concurrently with external beam radiation therapy to a dose of 50.4 Gy in 28 fractions. Radiation treatments will be administered daily, Monday thru Friday. Within one week prior to beginning chemotherapy and radiation treatments, a serum sample will be obtained from each patient. Patients will also have serum samples collected every two weeks during radiation, and on the last day of radiation therapy, as well as at their one month follow up visit after completion of radiation and prior to planned surgery. A final serum sample will be collected within one month after definitive surgery. Each serum sample collected will be less than 50 mL.
The study will involve obtaining serum samples from patients before during and after chemoradiation therapy. These serum samples will be analyzed to determine exosomal biomarker levels, which will be correlated with clinical, imaging, laboratory, and pathologic data obtained from the medical record.
Additional data from the patients' medical records will be collected, including demographic data, clinical information from notes in the medical record, radiology images and reports, results of diagnositic tests, and information from procedure notes and pathology reports.
Вмешательства
- Диагностический тест Blood Draw
Serum samples will be obtained from each patient enrolled
Первичные конечные точки
- Exosomal Biomarkers Assessment [Срок оценки: up to 10 years after treatment completion]
Вторичные конечные точки (2)
- Exosomal Expression [Срок оценки: up to 10 years after treatment completion]
- Exosomal Functionality Assessment [Срок оценки: up to 10 years after treatment completion]
Критерии участия
Критерии включения
- Male and Female Patients aged 18 and older
- histologically proven diagnosis of rectal adenocarcinoma
- will be receiving neoadjuvant chemoradiation therapy prior to a planned definitive surgical resection
Критерии исключения
- Age less than 18.
- Patients who are unable or unwilling to undergo definitive surgery.
- Patients with a prior history of pelvic external beam radiation, brachytherapy, or chemotherapy.
- Patients with a prior history of cancer (excluding non-melanoma skin cancers).
- Patients who are immunocompromised.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
США · 1 центр
- University of Kansas Medical Center/ Cancer Center — Kansas City
Идентификаторы
NCT: NCT03874559 · Protocol IIT-RE-0