The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study | NCT02736357

Studies
The Lymphoma Epidemiology of Outcomes (LEO) Cohort Study

NCT02736357

Sponsor

Mayo Clinic

Status

Withdrawn

Last Update Posted

Jun 22, 2023Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Non-Hodgkin Lymphoma

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Study restructured with Central IRB (NCT04996706); accruals reported there.

Expanded Access Info

Start Date

Jul 1, 2015Actual

Primary Completion Date

Apr 17, 2023Actual

Completion Date

Apr 17, 2023Actual

First Submitted Date

Apr 4, 2016

First Submission Date that Met QC Criteria

Apr 7, 2016

First Posted Date

Apr 13, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 20, 2023

Last Update Posted Date

Jun 22, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

James Cerhan, Principal Investigator, Mayo ClinicPrincipal Investigator

Lead Sponsor

Mayo ClinicOTHER

Collaborators

Name	Class
Emory University	OTHER
University of Iowa	OTHER
M.D. Anderson Cancer Center	OTHER
Washington University School of Medicine

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

20 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Event Free Survival (EFS)	Time from date of diagnosis to date of first defined event (disease progression, relapse or re-treatment for lymphoma, or death)	Short (<5 years), medium (5-10 years), and long-term (>10 years)
Lymphoma Specific Survival (LSS)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
James Cerhan, MD, PhD	Mayo Clinic	Principal Investigator
Christopher Flowers, MD	Emory University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Miami		Miami	Florida	33136	United States
Emory University

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
41707114	Derived	Ruan J, Chen Z, Larson MC, Bennani NN, Allen P, Mou E, Wallace D, Mehta-Shah N, Lossos IS, Malpica Castillo LE, Jaye DL, Vega F, Inghirami G, Pongas G, Akkad N, Casulo C, Martin P, Cohen JB, Habermann TM, Maurer MJ, Leonard JP, Friedberg JW, Kahl B, Cerhan JR, Flowers CR, Feldman AL. Patterns of care and clinical outcomes in systemic peripheral T-cell lymphoma: the LEO-MER prospective cohort study. Blood Adv. 2026 May 26;10(10):3480-3493. doi: 10.1182/bloodadvances.2025018455.

ID	Term
D008228	Lymphoma, Non-Hodgkin
D008223	Lymphoma

ID	Term
D009370	Neoplasms by Histologic Type
D009369	Neoplasms
D008232	Lymphoproliferative Disorders
D008206	Lymphatic Diseases