Assessment of Early-detection Based on Liquid Biopsy in Lymphoid Malignancies

Study Overview
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Brief Summary
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ASCEND-LYM is a prospective, multi-center, observational study aimed at detecting early stage lymphoma and constrcuting prognostic model by combined assays of cfDNA methylation and other biomarkers. The study will enroll approximately 493 participants including lymphoid malignancies and benign diseases.

Official Title
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Assessment of Early-detection Based on Liquid Biopsy in Lymphoid Malignancies: a Multi-center Prospective Observational Study

Conditions
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Lymphoma

Intervention / Treatment
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* Device: early detection test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for All Participants: Age 40-75 years at the day of consenting to the study. Able to provide a written informed consent. Additional Inclusion Criteria for Cancer Participants: No prior cancer treatment (local or systematic) prior to blood draw. High suspicious or pathologically confirmed lymphoid malignancies within 42 days prior to blood draw. Additional Inclusion Criteria for Benign Disease Participants: No prior radical treatment of the benign diseases prior to study blood draw Pathologically confirmed diagnosis of lymphoid benign diseases within 90 days prior to blood draw. Exclusion Criteria for All Participants: Insufficient qualified blood samples. During pregnancy or lactation. Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant. Recipient of blood transfusion within 7 days prior to blood draw. Recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw, such as rheumatic drugs (methotrexate, cyclophosphamide, or azathioprine), or endocrine drugs (tamoxifen). Additional Exclusion Criteria for Cancer Participants: With other known malignant tumors or multiple primary tumors. Lymphoid malignancies unable to comfirmed by imaging tests or pathological cancer diagnosis within 42 days after the blood draw. Additional Exclusion Criteria for Benign Disease Participants: With other known malignant tumors or comfirmed lymphoid malignancies. Lymphoid benign diseases unable to comfirmed by imaging tests or pathological cancer diagnosis within 42 days after the blood draw.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer Arm<br>Participants with new diagnosis of lymphoid malignancies, from whom blood samples will be collected. | Device: early detection test<br>* Blood collection and early detection testing<br>|
| Benign Arm<br>Participants with new diagnosis of benign lymphoid diseases, from whom blood samples will be collected. | Device: early detection test<br>* Blood collection and early detection testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity and specificity of early detection model for lymphoma based on cfDNA methylation or combined with other biomarkers. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity and specificity of the optimal model in lymphoma patients at different clinical stages. |  | 12 months | 
| The sensitivity and specificity of the optimal model in different subtypes of lymphoma patients. |  | 12 months | 
| The rate of high-risk patients found by prognostic model for lymphoma based on cfDNA methylation or combined with other biomarkers. |  | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lymphoma, early detection, liquid biopsy