Early detection of lymphoma using liquid biopsy techniques
Assessment of Early-detection Based on Liquid Biopsy in Lymphoid Malignancies: a Multi-center Prospective Observational Study
This study is testing if a new blood test can help find early signs of lymphoma in people aged 40-75, including those with other health conditions.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 493 (estimated) |
| Ages | 40 Years to 75 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | methotrexate, cyclophosphamide |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT05275036 on ClinicalTrials.gov |
What this trial studies
ASCEND-LYM is a prospective, multi-center observational study designed to detect early-stage lymphoma through the analysis of circulating free DNA (cfDNA) methylation and other biomarkers. The study aims to enroll approximately 493 participants, including those with lymphoid malignancies and benign diseases, to construct a prognostic model based on these assays. Participants will be aged 40-75 and must provide informed consent, with specific criteria for inclusion based on their cancer status. The study focuses on improving early detection methods for lymphoma, which could lead to better patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals aged 40-75 with high suspicion or confirmed lymphoid malignancies, as well as those with benign lymphoid diseases.
Not a fit: Patients who have received prior cancer treatment or those with insufficient qualified blood samples may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly enhance early detection of lymphoma, leading to timely interventions and improved patient survival rates.
How similar studies have performed: Other studies utilizing liquid biopsy techniques for early cancer detection have shown promise, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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: * 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.
Where this trial is running
Guangzhou
- SunYat-sen university cancer center — Guangzhou, China (Recruiting)
Study contacts
- Principal investigator: Huiqiang Huang, Ph.D — Department of Medical Oncology, Sun Yat-sen University Cancer Center
- Study coordinator: Huiqiang Huang, Ph.D
- Email: huanghq@sysucc.org.cn
- Phone: +86-020-87343350
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.