Lymphoma
Conditions
Keywords
lymphoma, early detection, liquid biopsy
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.
Interventions
DEVICEearly detection test
Blood collection and early detection testing
Sponsors
Guangzhou Burning Rock Dx Co., Ltd.
Sun Yat-sen University
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity and specificity of early detection model for lymphoma based on cfDNA methylation or combined with other biomarkers. | 12 months |
Secondary
| Measure | 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 |
Countries
China
Contacts
Primary ContactHuiqiang Huang, Ph.D
Backup ContactYan Gao, Ph.D
Outcome results
None listed