Clinical trial NCT04996706: Evaluation of Lymphoma Prognosis and Survivorship in Recently Diagnosed Patients, LEO Study
Official title: The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study Protocol
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Lymphoma, Non-Hodgkin
Keywords: Lymphatic Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Emory University
name: University of Iowa
name: M.D. Anderson Cancer Center
name: Washington University School of Medicine
name: University of Rochester
name: Weill Medical College of Cornell University
name: University of Miami
name: National Cancer Institute (NCI)
First posted: 2021-08-09
Enrollment: 21000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Newly diagnosed non-Hodgkin Lymphoma willing to provide a research blood sample, return enrollment and follow-up questionnaires, and allow access to medical records.

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.

Detailed description: 1. 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;
2. 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;
3. To collect a peripheral blood sample and maintain a central biorepository of DNA, serum, plasma, and buffy coat;
4. 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;
5. 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
6. 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.

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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Time Frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)
Secondary outcomes:
measure: Event Free Survival (EFS)
timeFrame: Time Frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)
measure: Lymphoma Specific Survival (LSS)
timeFrame: Time Frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Miami
country: United States
facility: University of Miami: Sylvester Comprehensive Cancer Center
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University School of Medicine in St. Louis
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Mayo Clinic
name: James R Cerhan, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: