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Evaluation of Lymphoma Prognosis and Survivorship in Recently Diagnosed Patients, LEO Study
Trial Status: active
This study evaluates the outcome of patients who have recently (within the past 6 months) been diagnosed with non-Hodgkins or Hodgkins lymphoma (HL). This study will evaluate medical and personal histories as well as blood, stool, other body-fluid and/or tumor tissue for current and future research studies on lymphoma. Studies using this information are being done to learn more about the clinical, environmental and genetic factors that may cause lymphoma in order to find new ways to prevent and treat these cancers.
Inclusion Criteria
Patients must be newly diagnosed within 6 months (180 days) of enrollment
Patients may have been treated as long as initial NHL or HL diagnosis is within 6 months of enrollment for enrollment into the LEO protocol
Patients must be 18 years or older
Patients will be recruited regardless of human immunodeficiency virus (HIV) status
Patients recruited outside of the 6 month from diagnosis window will be enrolled in relapsed/refractory protocol
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT04996706.
I. To extend recruitment at all 8 lymphoma epidemiology of outcomes (LEO) centers as part of LEO2.0 using a single institutional review board (IRB), with a goal of recruiting an additional 8,000 newly diagnosed non-Hodgkins Lymphoma (NHL) patients (with funding from the National Institutes of Health [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.
II. To review pathology at diagnosis and relapse of all LEO cases and maintain a central tumor bank for all NHL subtypes that includes an hematoxylin and eosin (H&E) slide, formalin-fixed, paraffin-embedded (FFPE) tissue samples in a tissue microarray (TMA), and extracted tumor deoxyribonucleic acid (DNA) and ribonucleic acid (RNA).
III. To collect a peripheral blood sample and saliva and maintain a central biorepository of DNA, serum, plasma, and buffy coat.
IV. 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.
V. 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.
VI. Facilitate research projects that use this infrastructure, promote interactions with National Cancer Institute (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.
OUTLINE: This is an observational study.
Patients undergo blood, saliva, and/or tissue sample collection on study. Patients also complete questionnaires and have their medical records reviewed on study.
