ASCEND-LYM: Assessment of Early-detection Based on Liquid Biopsy in Lymphoid Malignancies
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Cancer Arm Participants with new diagnosis of lymphoid malignancies, from whom blood samples will be collected. |
Device: early detection test
Blood collection and early detection testing
|
| Benign Arm Participants with new diagnosis of benign lymphoid diseases, from whom blood samples will be collected. |
Device: early detection test
Blood collection and early detection testing
|
Outcome Measures
Primary Outcome Measures
- The sensitivity and specificity of early detection model for lymphoma based on cfDNA methylation or combined with other biomarkers. [12 months]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
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:
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Insufficient qualified blood samples.
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During pregnancy or lactation.
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Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
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Recipient of blood transfusion within 7 days prior to blood draw.
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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.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | SunYat-sen university cancer center | Guangzhou | China |
Sponsors and Collaborators
- Sun Yat-sen University
- Guangzhou Burning Rock Dx Co., Ltd.
Investigators
- Principal Investigator: Huiqiang Huang, Ph.D, Department of Medical Oncology, Sun Yat-sen University Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- BRCD2022003