Assessment of Early-detection Based on Liquid Biopsy in Lymphoid Malignancies (ASCEND-LYM)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lymphoma
• Intervention / Treatment: Device: early detection test

• Study Type: Observational
• Enrollment (Anticipated): 493

Contacts and Locations

• Study Contact: Name: Huiqiang Huang, Ph.D; Phone Number: +86-020-87343350; Email: huanghq@sysucc.org.cn
• Study Contact Backup: Name: Yan Gao, Ph.D; Phone Number: +86-020-87343350; Email: gaoyan@sysucc.org.cn

Study Locations

• China
  • Guangzhou, China
    • Recruiting
    • SunYat-sen University Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be recruited from the participating medical center and assigned into two arms, including participants with new diagnosis of lymphoid malignancies and benign lymphoid diseases.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Guangzhou Burning Rock Dx Co., Ltd.
• Investigators: Principal Investigator: Huiqiang Huang, Ph.D, Department of Medical Oncology, Sun Yat-Sen University Cancer Center

Study record dates

Study Major Dates

• Study Start (Anticipated): May 31, 2022
• Primary Completion (Anticipated): June 30, 2023
• Study Completion (Anticipated): August 31, 2025

Study Registration Dates

• First Submitted: February 28, 2022
• First Submitted That Met QC Criteria: March 9, 2022
• First Posted (Actual): March 11, 2022

Study Record Updates

• Last Update Posted (Actual): April 14, 2022
• Last Update Submitted That Met QC Criteria: April 6, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: lymphoma, early detection, liquid biopsy
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Neoplasms; Lymphoma
• Other Study ID Numbers: BRCD2022003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No