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The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study

Sponsor
Mayo Clinic (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02736357
Collaborator
Emory University (Other), University of Iowa (Other), M.D. Anderson Cancer Center (Other), Washington University School of Medicine (Other), University of Rochester (Other), Weill Medical College of Cornell University (Other), University of Miami (Other)
12,900
Enrollment
8
Locations
133
Anticipated Duration (Months)
1612.5
Patients Per Site
12.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Newly diagnosed non-Hodgkin lymphoma (NHL) patients will be recruited from each center participating in the LEO cohort. At time of consent, participants will be asked to completed several questionnaires collecting health history, current medical and quality of life questions. Patients will also provide a baseline blood sample that will processed locally and stored centrally for future research use. Additionally, consent is given for use of excess clinical tumor tissue for research use.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    12900 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study
    Actual Study Start Date :
    Jul 1, 2015
    Anticipated Primary Completion Date :
    Aug 1, 2026
    Anticipated Study Completion Date :
    Aug 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Overall Survival (OS) [Short (<5 years), medium (5-10 years), and long-term (>10 years)]

      Time from date of diagnosis to date of death

    Secondary Outcome Measures

    1. Event Free Survival (EFS) [Short (<5 years), medium (5-10 years), and long-term (>10 years)]

      Time from date of diagnosis to date of first defined event (disease progression, relapse or re-treatment for lymphoma, or death)

    2. Lymphoma Specific Survival (LSS) [Short (<5 years), medium (5-10 years), and long-term (>10 years)]

      Time from date of diagnosis to date of death due to lymphoma

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Miami Miami Florida United States 33136
    2 Emory University Atlanta Georgia United States 30322
    3 University of Iowa Iowa City Iowa United States 52242
    4 Mayo Clinic Rochester Minnesota United States 55902
    5 Washington University Saint Louis Missouri United States 63130
    6 Weill Cornell Medical College New York New York United States 10021
    7 University of Rochester Rochester New York United States 14642
    8 MD Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • Mayo Clinic
    • Emory University
    • University of Iowa
    • M.D. Anderson Cancer Center
    • Washington University School of Medicine
    • University of Rochester
    • Weill Medical College of Cornell University
    • University of Miami

    Investigators

    • Principal Investigator: James Cerhan, MD, PhD, Mayo Clinic
    • Principal Investigator: Christopher Flowers, MD, Emory University

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    James Cerhan, Principal Investigator, Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT02736357
    Other Study ID Numbers:
    • 15-007282
    First Posted:
    Apr 13, 2016
    Last Update Posted:
    Jun 29, 2022
    Last Verified:
    Jun 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by James Cerhan, Principal Investigator, Mayo Clinic
    Lymphoma
    Cohort
    non-Hodgkin
    Additional relevant MeSH terms:
    Lymphoma

    Study Results

    No Results Posted as of Jun 29, 2022