Evaluation of Lymphoma Prognosis and Survivorship in Recently Diagnosed Patients, LEO Study

NCT04996706 | Enrolling By Invitation

• 3 other identifiers: 21-001804U01CA195568-06A1NCI-2022-02481
• Study Type: observational
• Target: 21,000
• Locations: 1 country
• Sites: 10

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.

Conditions

Lymphoma, Non-Hodgkin

Keywords

Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• years of age or older

You may not qualify if:

• \- Lymphoma diagnosis greater than 184 days from date of consent

Sponsors & Collaborators

• Mayo Clinic: lead
• Emory University: collaborator
• University of Iowa: collaborator
• M.D. Anderson Cancer Center: collaborator
• Washington University School of Medicine: collaborator
• University of Rochester: collaborator
• Weill Medical College of Cornell University: collaborator
• University of Miami: collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (10)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

Location

University of Miami: Sylvester Comprehensive Cancer Center

Miami, Florida, 33136, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

Washington University School of Medicine in St. Louis

St Louis, Missouri, 63110, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphatic Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Immune System Diseases

Condition Hierarchy (Ancestors)

Lymphoma; Hemic and Lymphatic Diseases

Study Officials

• James R Cerhan, MD,PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2021
• First Posted: August 9, 2021
• Study Start: August 16, 2021
• Primary Completion (Estimated): March 31, 2031
• Study Completion (Estimated): March 31, 2031
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Will become available upon publication
• Access Criteria: Data sharing can occur only after going through group approvals.

Locations

US (10)