The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study

NCT02736357 | Withdrawn DMC

• 1 other identifier: 15-007282
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 8

Brief Summary

The goal of this infrastructure grant is to establish and maintain a cohort of over 12,000 non-Hodgkin lymphoma (NHL) patients to support broad and cutting-edge research that identifies clinical (including co-morbid diseases), epidemiologic (including lifestyle and other exposures), host genetic, tumor, and treatment factors, as well as the interaction among these factors, on short and long-term outcomes. These efforts will identify new approaches to improve the survival and well-being of NHL patients.

Conditions

Non-Hodgkin Lymphoma

Keywords

Lymphoma; Cohort; non-Hodgkin

Outcome Measures

Primary Outcomes (1)

• Overall Survival (OS)

  Time from date of diagnosis to date of death

  Short (<5 years), medium (5-10 years), and long-term (>10 years)

Secondary Outcomes (2)

• Event Free Survival (EFS)

  Short (<5 years), medium (5-10 years), and long-term (>10 years)

• Lymphoma Specific Survival (LSS)

  Short (<5 years), medium (5-10 years), and long-term (>10 years)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• 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

Study Sites (8)

University of Miami

Miami, Florida, 33136, United States

Location

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

St Louis, Missouri, 63130, United States

Location

Weill Cornell Medical College

New York, New York, 10021, United States

Location

University of Rochester

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

Research blood draw collected at baseline. Research blood processed and stored as plasma, serum and germline DNA. Tissue in excess of diagnosis stored in formalin fixed paraffin embedded (FFPE) cored for use in Tissue Micro Array (TMA) and extraction of DNA and RNA from tumor.

MeSH Terms

Conditions

Lymphoma, Non-Hodgkin; Lymphoma

Condition Hierarchy (Ancestors)

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

Study Officials

• James Cerhan, MD, PhD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

• Christopher Flowers, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 13, 2016
• Study Start: July 1, 2015
• Primary Completion: April 17, 2023
• Study Completion: April 17, 2023
• Last Updated: June 22, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)