Sample Collection for Ongoing Research and Product Evaluation Study - Non-Hodgkin Lymphoma (SCORE-NHL)
SCORE-NHL
1 other identifier
observational
200
1 country
1
Brief Summary
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)").
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2026
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 17, 2026
CompletedStudy Start
First participant enrolled
July 27, 2026
CompletedFirst Posted
Study publicly available on registry
August 6, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2032
August 6, 2026
July 1, 2026
5.7 years
July 17, 2026
August 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
3 Years
Secondary Outcomes (1)
Secondary Outcome - Blood and Residual Tissue Specimen Collection from 160 Completed Participants for Disease Assay Development for Blood-Based Cancer Monitoring and Detection.
3 Years
Eligibility Criteria
Participants 18 years of age or older diagnosed with aggressive Stage I to IV non-Hodgkin lymphoma prior to receiving treatment.
You may qualify if:
- 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.
- Patients who are planning to receive six cycles of first-line therapy with an anthracycline-based chemotherapy regimen as per the standard of care.
- Radiographically measurable disease with at least one hypermetabolic lesion by Lugano classification on baseline FDG PET/CT or FDG PET (radiographically measurable disease by CT with intravenous contrast is allowed if FDG-PET/CT is not available).
- Able to tolerate blood draws according to Natera standard process.
You may not qualify if:
- 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.
- Clinical ctDNA-MRD testing by any platform.
- Concurrent treatment that includes an investigational agent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Natera, Inc.lead
Study Sites (1)
Natera, Inc.
Austin, Texas, 78753, United States
Biospecimen
Whole blood and tissue samples
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2026
First Posted
August 6, 2026
Study Start
July 27, 2026
Primary Completion (Estimated)
April 1, 2032
Study Completion (Estimated)
April 1, 2032
Last Updated
August 6, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share