Clinical Trial Details
— Status: Enrolling by invitation
Administrative data
| NCT number |
NCT04996706 |
| Other study ID # |
21-001804 |
| Secondary ID |
U01CA195568-06A1 |
| Status |
Enrolling by invitation |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
August 16, 2021 |
| Est. completion date |
August 1, 2026 |
Study information
| Verified date |
October 2023 |
| Source |
Mayo Clinic |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The goal of this infrastructure protocol is to build and maintain a large and diverse
observational cohort study to support broad and cutting-edge research focused on NHL
prognosis and survivorship. The LEO cohort will promote identification of clinical (including
co-morbid diseases), epidemiologic (including lifestyle and other exposures), host genetic,
tumor, and treatment factors that impact multiple outcomes (including event-free, overall and
lymphoma-specific survival; new onset comorbidities; and patient-reported outcomes). This
resource also will allow examination of the interaction among these factors in order to
better understand the clinical and molecular epidemiology of outcomes in NHL. Ultimately,
this approach will drive discovery and validation of treatment endpoints, improve
prognostication, and identify novel approaches to improve short and long-term outcomes for
NHL patients.
Description:
1. To extend recruitment at all 8 LEO centers as part of LEO2.0 using a single IRB, with a
goal of recruiting an additional 8,000 newly diagnosed NHL patients (with funding from
the NIH renewal grant to enroll 3,400) focused on Hispanic (N=900), African Americans
(N=580), and Asian (N=200) participants (doubling the current sample size for these
groups; adolescent and young adult patients age 18-39 years (N=870; 87% increase); and
non-metro and rural patients of all ages and race/ethnicities (N=1,208, 72% increase)
for a total cohort of over 21,000 patients;
2. To review pathology at diagnosis and relapse of all LEO cases and maintain a central
tumor bank for selected NHL subtypes that includes an H&E slide, formalin-fixed,
paraffin-embedded (FFPE) tissue samples in a tissue microarray (TMA), and extracted
tumor DNA and RNA;
3. To collect a peripheral blood sample and maintain a central biorepository of DNA, serum,
plasma, and buffy coat;
4. To continue to prospectively follow all participants in the LEO cohort to ascertain
disease progression/relapse, retreatment, transformation, second cancers, survival
(including cause of death), updated exposures, patient-reported outcomes (PROs), and
other long-term health outcomes;
5. To annotate and harmonize all cases with clinical, epidemiologic, pathology and
treatment data, including development of new informatics enhancements to capture
clinical data from electronic health records (EHRs), digital pathology, and radiology
images, geocoded data from residence at diagnosis with linkage to public databases to
enhance data on environmental exposures and socioeconomic factors; and
6. Facilitate research projects that use this infrastructure, promote interactions with
NCI-supported clinical trials networks, patient advocacy groups, and other
collaborators, and to make the LEO resource accessible to patients and providers with
publicly available risk calculators based on LEO data.
