Evaluation of Lymphoma Prognosis and Survivorship in Recently Diagnosed Patients, LEO Study
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
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Lymphoma, Non-Hodgkin. 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
The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study Protocol
Обзор
The goal of this infrastructure protocol is to build and maintain a large and diverse observational cohort study to support broad and cutting-edge research focused on NHL prognosis and survivorship. The LEO cohort will promote identification of clinical (including co-morbid diseases), epidemiologic (including lifestyle and other exposures), host genetic, tumor, and treatment factors that impact multiple outcomes (including event-free, overall and lymphoma-specific survival; new onset comorbidities; and patient-reported outcomes). This resource also will allow examination of the interaction among these factors in order to better understand the clinical and molecular epidemiology of outcomes in NHL. Ultimately, this approach will drive discovery and validation of treatment endpoints, improve prognostication, and identify novel approaches to improve short and long-term outcomes for NHL patients.
Подробное описание
1. To extend recruitment at all 8 LEO centers as part of LEO2.0 using a single IRB, with a goal of recruiting an additional 8,000 newly diagnosed NHL patients (with funding from the NIH renewal grant to enroll 3,400) focused on Hispanic (N=900), African Americans (N=580), and Asian (N=200) participants (doubling the current sample size for these groups; adolescent and young adult patients age 18-39 years (N=870; 87% increase); and non-metro and rural patients of all ages and race/ethnicities (N=1,208, 72% increase) for a total cohort of over 21,000 patients; 2. To review pathology at diagnosis and relapse of all LEO cases and maintain a central tumor bank for selected NHL subtypes that includes an H\&E slide, formalin-fixed, paraffin-embedded (FFPE) tissue samples in a tissue microarray (TMA), and extracted tumor DNA and RNA; 3. To collect a peripheral blood sample and maintain a central biorepository of DNA, serum, plasma, and buffy coat; 4. To continue to prospectively follow all participants in the LEO cohort to ascertain disease progression/relapse, retreatment, transformation, second cancers, survival (including cause of death), updated exposures, patient-reported outcomes (PROs), and other long-term health outcomes; 5. To annotate and harmonize all cases with clinical, epidemiologic, pathology and treatment data, including development of new informatics enhancements to capture clinical data from electronic health records (EHRs), digital pathology, and radiology images, geocoded data from residence at diagnosis with linkage to public databases to enhance data on environmental exposures and socioeconomic factors; and 6. Facilitate research projects that use this infrastructure, promote interactions with NCI-supported clinical trials networks, patient advocacy groups, and other collaborators, and to make the LEO resource accessible to patients and providers with publicly available risk calculators based on LEO data.
Первичные конечные точки
- Overall Survival (OS) [Срок оценки: Time Frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)]
Вторичные конечные точки (2)
- Event Free Survival (EFS) [Срок оценки: Time Frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)]
- Lymphoma Specific Survival (LSS) [Срок оценки: Time Frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)]
Критерии участия
Критерии включения
- Newly diagnosed within 6 months (180 days) of enrollment
- Patients may have been treated as long as initial non-Hodgkins Lymphoma (NHL) or Hodgkin's Lymphoma (HL) diagnosis is within 6 months of enrollment
- 18 years of age or older
Критерии исключения
- Does not meet inclusion criteria
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 · 12 центров
- Mayo Clinic in Arizona — Scottsdale
- Mayo Clinic in Florida — Jacksonville
- University of Miami: Sylvester Comprehensive Cancer Center — Miami
- Emory University Hospital Midtown — Atlanta
- Winship Cancer Institute of Emory University — Atlanta
- Emory St. Joseph's Hospital — Atlanta
- University of Iowa — Iowa City
- Mayo Clinic — Rochester
- … и ещё 4 центра
Идентификаторы
NCT: NCT04996706 · 21-001804 · U01CA195568 · U01CA308978