Clinical trial NCT02736357: The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study
Official title: The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Non-Hodgkin Lymphoma
Keywords: Lymphoma
Cohort
non-Hodgkin
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Emory University
name: University of Iowa
name: M.D. Anderson Cancer Center
name: Washington University School of Medicine
name: University of Rochester
name: Weill Medical College of Cornell University
name: University of Miami
First posted: 2016-04-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility 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

Primary outcomes:
measure: Overall Survival (OS)
timeFrame: Short (<5 years), medium (5-10 years), and long-term (>10 years)
Secondary outcomes:
measure: Event Free Survival (EFS)
timeFrame: Short (<5 years), medium (5-10 years), and long-term (>10 years)
measure: Lymphoma Specific Survival (LSS)
timeFrame: Short (<5 years), medium (5-10 years), and long-term (>10 years)
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami
state: Florida
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Rochester
country: United States
facility: University of Rochester
state: New York
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: Mayo Clinic
name: James Cerhan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Christopher Flowers, MD
role: PRINCIPAL_INVESTIGATOR
References: