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Enrolling by Invitation

NCT Number: NCT04996706

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

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About this study

  • 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;
  • 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;
  • To collect a peripheral blood sample and maintain a central biorepository of DNA, serum, plasma, and buffy coat;
  • 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;
  • 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
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • Does not meet inclusion criteria

Treatment and study plan

Primary outcomes

  1. Overall Survival (OS)

    Time frame: Time Frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)

    Time from date of diagnosis to date of death

Secondary outcomes

  1. Event Free Survival (EFS)

    Time frame: Time Frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)

    Time from date of diagnosis to date of first defined event (disease progression, relapse or re-treatment for lymphoma, or death)

  2. Lymphoma Specific Survival (LSS)

    Time frame: Time Frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)

    Time from date of diagnosis to date of death due to lymphoma

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • Emory University
  • M.D. Anderson Cancer Center
  • National Cancer Institute (NCI)
  • University of Iowa
  • University of Miami
  • University of Rochester
  • Washington University School of Medicine
  • Weill Medical College of Cornell University

Registry information

Official study title

The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study Protocol

Acronym: LEO

Important dates

Study start
2021
Primary completion
2031
Study completion
2031
First posted
Aug 9, 2021
Registry last updated
Jul 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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