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

Lymphoma Clinical Trial

— ASCEND-LYM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05275036
• Other study ID #: BRCD2022003
• Status: Recruiting
• Start date: May 31, 2022
• Est. completion date: August 31, 2025

Study information

• Verified date: April 2022
• Source: Sun Yat-sen University
• Contact: Huiqiang Huang, Ph.D
• Phone: +86-020-87343350
• Email: huanghq[@]sysucc.org.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 493
• Est. completion date: August 31, 2025
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphoma
• Neoplasms

Intervention

Device:
• early detection test
Blood collection and early detection testing

Locations

Country	Name	City	State
China	SunYat-sen university cancer center	Guangzhou

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Guangzhou Burning Rock Dx Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The sensitivity and specificity of early detection model for lymphoma based on cfDNA methylation or combined with other biomarkers.		12 months
Secondary	The sensitivity and specificity of the optimal model in lymphoma patients at different clinical stages.		12 months
Secondary	The sensitivity and specificity of the optimal model in different subtypes of lymphoma patients.		12 months
Secondary	The rate of high-risk patients found by prognostic model for lymphoma based on cfDNA methylation or combined with other biomarkers.		24 months