Recruiting

Biomarkers Research

Sponsor:

Natera, Inc.

Code:

NCT07750886

Conditions

Non-Hodgkin Lymphoma

T-Cell Lymphoma

Diffuse Large B-Cell Lymphoma

High-Grade B-Cell Lymphoma

Primary Mediastinal B-Cell Lymphoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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)").

Conditions

Non-Hodgkin Lymphoma

T-Cell Lymphoma

Diffuse Large B-Cell Lymphoma

High-Grade B-Cell Lymphoma

Primary Mediastinal B-Cell Lymphoma

Study ID

NCT07750886

Start date

Jul 27, 2026

Status verified date

Jul, 2026

Completion date

Apr, 2032

Anticipated

Primary completion date

Apr, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Patient is at least 18 years of age or older.
2. Eastern Cooperative Oncology Group performance status ≤ 2.
3. Patients who are able to consent to and provide residual tumor tissue for research. Bone marrow specimens are excluded as acceptable tumor tissue.
4. 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.
5. Patients who are planning to receive six cycles of first-line therapy with an anthracycline-based chemotherapy regimen as per the standard of care.
6. 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).
7. Able to tolerate blood draws according to Natera standard process.

Exclusion Criteria:

1. 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.
2. Diagnosis of aggressive NHL that has a circulating, leukemic component, bone marrow or blood involvement.
3. History of an allogeneic stem cell transplant or other organ transplant.
4. 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.
5. Clinical ctDNA-MRD testing by any platform.
6. Concurrent treatment that includes an investigational agent.

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Primary Outcome - Blood and Residual Tissue Specimen Collection from 160 Completed Participants for Blood-Based Cancer Monitoring and Detection and Cancer Assay Development. [ Time Frame: 3 Years ]

Central Contacts and Locations

Central contacts

Locations

Natera, Inc.

Recruiting

Austin, Texas, United States, 78753

Contacts

Radhakrishnan Ramchandren, MD

650-489-9050

More Information

Sponsor

Natera, Inc.

Last update posted

Aug 6, 2026

Last verified

Jul, 2026

Keywords

  • Non-Hodgkin Lymphoma
  • T-Cell Lymphoma
  • Diffuse Large B Cell Lymphoma
  • Primary Mediastinal B-Cell Lymphoma
  • Peripheral T-Cell Lymphoma
  • Anaplastic Large Cell Lymphoma
  • Transformed Follicular Lymphoma
  • Follicular Lymphoma grade 3B
  • Follicular Lymphoma
  • NHL
  • DLBCL
  • HGBCL
  • High-Grade B-Cell Lymphoma
  • PMBCL
  • PTCL
  • FL
  • ALCL

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Natera, Inc. on 2026-08-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.