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

Sun Yat-sen University

Status: Enrolling

Conditions: Lymphoma

Treatments: Device: early detection test

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05275036

BRCD2022003

Details and patient eligibility

About

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.

Enrollment: 493 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

493 participants in 2 patient groups

Cancer Arm

Description:

Participants with new diagnosis of lymphoid malignancies, from whom blood samples will be collected.

Treatment:

Device: early detection test

Benign Arm

Description:

Participants with new diagnosis of benign lymphoid diseases, from whom blood samples will be collected.

Treatment:

Device: early detection test