Non Hodgkin Lymphoma Clinical Trial

Lymphoma Epidemiology of Outcomes Cohort Years 6-10

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.

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Full Description

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.

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Eligibility Criteria

Inclusion Criteria:

Newly diagnosed non-Hodgkin Lymphoma (NHL), within 183 days of enrollment
Patients may have been treated as long as initial NHL diagnosis is within 6 months of enrollment
18 years of age or older

Exclusion Criteria:

- Lymphoma diagnosis greater than 184 days from date of consent

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

20000

Study ID:

NCT04996706

Recruitment Status:

Enrolling by invitation

Sponsor:

Mayo Clinic

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There are 8 Locations for this study

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University of Miami: Sylvester Comprehensive Cancer Center
Miami Florida, 33136, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
University of Iowa
Iowa City Iowa, 52242, United States
Mayo Clinic
Rochester Minnesota, 55902, United States
• Washington School of Medicine in St. Louis
Saint 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

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Estimated Enrollment:

20000

Study ID:

NCT04996706

Recruitment Status:

Enrolling by invitation

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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