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Evaluation of Lymphoma Prognosis and Survivorship in Recently Diagnosed Patients, LEO Study

Cancer Type
Hodgkin Lymphoma
Non-Hodgkin Lymphoma
Trial Phase
18 Years and older, Male and Female
Study Type
Protocol IDs
21-001804 (primary)
Study Sponsor
Mayo Clinic in Rochester


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.


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 selected 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 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, stool, and/or tissue sampling on study. Patients also complete questionnaires and have their medical records reviewed on study.


  1. Patients must be newly diagnosed within 6 months (180 days) of enrollment
  2. 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
  3. Patients must be 18 years or older
  4. Patients will be recruited regardless of human immunodeficiency virus (HIV) status
  5. Patients recruited outside of the 6 month from diagnosis window will be enrolled in relapsed/refractory protocol

Treatment Sites in Georgia

Winship Cancer Institute of Emory University

1365 Clifton Road NE
Building C
Atlanta, GA 30322

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.