LEO: Lymphoma Epidemiology of Outcomes Cohort Years 6-10
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
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Detailed Description
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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;
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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;
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To collect a peripheral blood sample and maintain a central biorepository of DNA, serum, plasma, and buffy coat;
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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;
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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
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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.
Study Design
Outcome Measures
Primary Outcome Measures
- Overall Survival (OS) [Time Frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)]
Time from date of diagnosis to date of death
Secondary Outcome Measures
- Event Free Survival (EFS) [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)
- Lymphoma Specific Survival (LSS) [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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Newly diagnosed non-Hodgkin Lymphoma (NHL), within 183 days of enrollment
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Patients may have been treated as long as initial NHL diagnosis is within 6 months of enrollment
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18 years of age or older
Exclusion Criteria:
- Lymphoma diagnosis greater than 184 days from date of consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Miami: Sylvester Comprehensive Cancer Center | Miami | Florida | United States | 33136 |
| 2 | Winship Cancer Institute of Emory University | Atlanta | Georgia | United States | 30322 |
| 3 | University of Iowa | Iowa City | Iowa | United States | 52242 |
| 4 | Mayo Clinic | Rochester | Minnesota | United States | 55902 |
| 5 | • Washington School of Medicine in St. Louis | Saint Louis | Missouri | United States | 63110 |
| 6 | Weill Cornell Medical College | New York | New York | United States | 10065 |
| 7 | University of Rochester Medical Center | Rochester | New York | United States | 14642 |
| 8 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Mayo Clinic
- National Cancer Institute (NCI)
- Emory University
- University of Iowa
- M.D. Anderson Cancer Center
- Washington University School of Medicine
- University of Rochester
- Weill Medical College of Cornell University
- University of Miami
Investigators
- Principal Investigator: James R Cerhan, M.D.,PhD, Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.- 21-001804
- U01CA195568-06A1