The SCORE-NHL study is a prospective, multi-center, study designed to collect data and biological samples from participants diagnosed with aggressive Stage I to IV non-Hodgkin Lymphoma (NHL). Study participants will undergo research blood collections of up to 60 mL as well as residual tissue collection, collected as part of a standard of care procedure, for use in research. Collected samples and data will be analyzed to evaluate biomarkers associated with development and validation of cancer monitoring and detection assays ("Natera cancer monitoring and detection test(s)").
Patient is at least 18 years of age or older.
Eastern Cooperative Oncology Group performance status ≤ 2.
Patients who are able to consent to and provide residual tumor tissue for research. Bone marrow specimens are excluded as acceptable tumor tissue.
Patients with a new diagnosis of Stage I to IV aggressive non-Hodgkin lymphoma (NHL) including all aggressive large B-cell lymphoma (DLBCL, HGBCL, PMBCL), T-cell lymphoma (PTCL, ALCL), follicular lymphoma (FL) grade 3B, or transformed FL.
Diagnosis of an indolent lymphoma that does not require immediate intervention, Hodgkin lymphoma, small lymphocytic lymphoma (SLL), or chronic lymphocytic leukemia (CLL). Other NHL diagnoses beyond DLBCL, aggressive TCLs, and grade 3B or transformed FL.
Diagnosis of aggressive NHL that has a circulating, leukemic component, bone marrow or blood involvement.
History of an allogeneic stem cell transplant or other organ transplant.
Prior history and treatment for any cancer within the past year or another active cancer, with the exception of participants who have undergone surgical removal of skin squamous cell or basal cell cancers.
Participants 18 years of age or older diagnosed with aggressive Stage I to IV non-Hodgkin lymphoma prior to receiving treatment.
Cohort
Prospective
Not listed
Primary Outcome - Blood and Residual Tissue Specimen Collection from 160 Completed Participants for Blood-Based Cancer Monitoring and Detection and Cancer Assay Development.
The primary outcome is the collection of clinically characterized, de-identified whole blood and residual tissue specimens from 160 completed participants newly diagnosed with cancer. The data and specimens will be used for the development and validation of blood-based cancer monitoring and detection assays.
Secondary Outcome - Blood and Residual Tissue Specimen Collection from 160 Completed Participants for Disease Assay Development for Blood-Based Cancer Monitoring and Detection.
The secondary outcome is to collect clinically characterized, de-identified whole blood and residual tissue specimens from 160 completed participants newly diagnosed with cancer. The data and specimens will be used for the development and validation of a broader range of blood-based disease monitoring assays.
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