NCT04996706|Enrolling By Invitation
Evaluation of Lymphoma Prognosis and Survivorship in Recently Diagnosed Patients, LEO Study
LEO
The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study Protocol
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LEO
The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study Protocol
Sponsor study identifier
Secondary identifiers
NIH
NIH
observational
21,000
1 country
12
Study Start
August 16, 2021
Actual (reported)Primary Completion
March 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
March 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 3, 2021
Actual (reported)August 9, 2021
Actual (reported)August 16, 2021
Actual (reported)March 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Overall Survival (OS)
Time from date of diagnosis to date of death
Time Frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)
Event Free Survival (EFS)
Time Frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)
Lymphoma Specific Survival (LSS)
Time Frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)
Newly diagnosed non-Hodgkin Lymphoma (NHL) willing to provide a research blood, saliva, stool, and/or tumor tissue sample, return enrollment and follow-up questionnaires, and allow access to medical records.
Mayo Clinic in Arizona
Scottsdale, Arizona, 85259, United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980, United States
University of Miami: Sylvester Comprehensive Cancer Center
Miami, Florida, 33136, United States
Emory University Hospital Midtown
Atlanta, Georgia, 30308, United States
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322, United States
Emory St. Joseph's Hospital
Atlanta, Georgia, 30342, United States
University of Iowa
Iowa City, Iowa, 52242, United States
1. Blood Collection 2. DNA - Blood 3. Tumor DNA and RNA Extraction 4. Formalin Fixed Paraffin Embedded Tissue (FFPE) H\&E Slide 5. Tissue Microarrays (TMA) 6. Clinical Residual
James R Cerhan, MD,PhD
Mayo Clinic
First Submitted
August 3, 2021
First Posted
August 9, 2021
Study Start
August 16, 2021
Actual (reported)Primary Completion
March 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Contact the study team to confirm eligibility.
Mayo Clinic
Rochester, Minnesota, 55902, United States
Washington University School of Medicine in St. Louis
St Louis, Missouri, 63110, United States
Weill Cornell Medical College
New York, New York, 10065, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Study Completion
March 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 13, 2026
Record last verified: 2026-07
Sharing of data can be requested through the LEO Cohort website.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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