Sample Collection for Ongoing Research and Product Evaluation Study - Non-Hodgkin Lymphoma (SCORE-NHL)

Обзор

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)").

Подробное описание

The study is designed to evaluate the clinical performance of Natera's molecular residual disease (MRD) assays in detecting ctDNA in patients with aggressive Stage I to IV non-Hodgkin Lymphoma (NHL). The goal is to assess the ability of the assay to identify minimal residual disease, monitor disease recurrence, and evaluate treatment response following standard-of-care therapy. No individual test results from the study testing will be provided to participants or their treating clinicians.

Participants who meet the study inclusion criteria will be invited to enroll in the study. Informed consent form (ICF) (paper or electronic) will be signed by the participant prior to study procedures. Participants will provide study-specific blood samples.

Participants may be followed for up to three years. During the first two years, blood samples will be collected at protocol-defined timepoints. Participants will then complete one year of data-only follow-up.

Tissue Sample Collection Residual tissue samples, collected as part of standard-of-care procedures, will also be obtained for study purposes.

Первичные конечные точки

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

Вторичные конечные точки (1)

• Secondary Outcome - Blood and Residual Tissue Specimen Collection from 160 Completed Participants for Disease Assay Development for Blood-Based Cancer Monitoring and Detection. [Срок оценки: 3 Years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

США · 1 центр

• Natera, Inc. — Austin

Идентификаторы

NCT: NCT07750886 · 25-097-NCP

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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