Lymphoma Epidemiology of Outcomes Cohort Years 6-10

Lymphoma, Non-Hodgkin Clinical Trial

— LEO  

Official title:

Lymphoma Epidemiology of Outcomes Cohort Years 6-10

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04996706
• Other study ID #: 21-001804
• Secondary ID: U01CA195568-06A1
• Status: Enrolling by invitation
• Start date: August 16, 2021
• Est. completion date: August 1, 2026

Study information

• Verified date: October 2023
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 20000
• Est. completion date: August 1, 2026
• Est. primary completion date: August 1, 2026
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Locations

Country	Name	City	State
United States	Winship Cancer Institute of Emory University	Atlanta	Georgia
United States	MD Anderson Cancer Center	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	University of Miami: Sylvester Comprehensive Cancer Center	Miami	Florida
United States	Weill Cornell Medical College	New York	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	University of Rochester Medical Center	Rochester	New York
United States	• Washington School of Medicine in St. Louis	Saint Louis	Missouri

Sponsors (9)

Lead Sponsor	Collaborator
Mayo Clinic	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

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Secondary	Event Free Survival (EFS)	Time from date of diagnosis to date of first defined event (disease progression, relapse or re-treatment for lymphoma, or death)	Time Frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)
Secondary	Lymphoma Specific Survival (LSS)	Time from date of diagnosis to date of death due to lymphoma	Time Frame: Short (<5 years), medium (5-10 years), and long-term (>10 years)

External Links

•   Mayo Clinic Clinical Trials