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The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study (LEO)

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ClinicalTrials.gov Identifier: NCT02736357
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : June 14, 2018
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
James Cerhan, Mayo Clinic

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
Non-Hodgkin Lymphoma

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 Type : Observational [Patient Registry]
Estimated Enrollment : 12900 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 20 Years
Official Title: The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study
Study Start Date : July 2015
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma




Primary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: 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) [ Time Frame: 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) [ Time Frame: Short (<5 years), medium (5-10 years), and long-term (>10 years) ]
    Time from date of diagnosis to date of death due to lymphoma


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.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02736357


Contacts
Contact: Julianne Lunde 507-266-2657 lunde.julianne@mayo.edu

Locations
United States, Florida
University of Miami Recruiting
Miami, Florida, United States, 33136
Contact: Neslihan Yorukoglu    305-243-2712    nyorukoglu@miami.edu   
Principal Investigator: Izidore Lossos, MD         
Sub-Investigator: Francisco Vega, MD, PhD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Barbara Copeland    404-778-3942    bjcopel@emory.edu   
Principal Investigator: Christopher Flowers, MD         
Sub-Investigator: Leon Bernal, MD         
Sub-Investigator: Joe Lipscomb, MD         
Sub-Investigator: Kevin Ward, PhD         
Sub-Investigator: David Jaye, MD         
Sub-Investigator: Karen Mann, MD, PhD         
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Contact: Ashley McCarthy    319-467-5839    ashley-mccarthy@uiowa.edu   
Principal Investigator: Brian Link, MD         
Sub-Investigator: Sergei Syrbu, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55902
Contact: Julianne Lunde    507-266-2657    lunde.julianne@mayo.edu   
Principal Investigator: James Cerhan, MD, PhD         
Sub-Investigator: Thomas Habermann, MD         
Sub-Investigator: Susan Slager, PhD         
Sub-Investigator: Carrie Thompson, MD         
Sub-Investigator: Kathleen Yost, PhD         
Sub-Investigator: Andrew Feldman, MD         
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Katherine Eckert    314-747-7638    katherine.eckert@dom.wustl.edu   
Principal Investigator: Brad Kahl, MD         
Sub-Investigator: Kenneth Carson, MD         
Sub-Investigator: Karin Vij, MD         
United States, New York
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Arcania Garcia    212-746-2190    arg2006@med.cornell.edu   
Contact: Channy Kong    212-746-1305    chk2031@med.cornell.edu   
Principal Investigator: Peter Martin, MD         
Sub-Investigator: Giorgio Inghirami, MD         
University of Rochester Recruiting
Rochester, New York, United States, 14642
Contact: Don Bruns       Don_Burns@urmc.rochester.edu   
Principal Investigator: Johnathan Friedberg, MD         
Principal Investigator: Carla Casulo, MD         
Sub-Investigator: Richard Burack, MD         
United States, Texas
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Sandy Ashkar    832-750-1554    saashkar@mdanderson.org   
Principal Investigator: Loretta Nastoupil, MD         
Sub-Investigator: Timothy McDonnell, MD, PhD         
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

Responsible Party: James Cerhan, Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02736357     History of Changes
Other Study ID Numbers: 15-007282
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: June 14, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make individual participant data (IPD) available.

Keywords provided by James Cerhan, Mayo Clinic:
Lymphoma
Cohort
non-Hodgkin

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases