AssesSment of Early deteCtion basEd oN liquiD Biopsy in Intracranial Tumors (ASCEND-BRAIN)

Zhujiang Hospital

Status: Enrolling

Conditions: Intracranial Tumors

Treatments: Device: early detection test

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT05679089

RSCD2022009

Details and patient eligibility

About

ASCEND-BRAIN is a prospective, observational study aimed at early-detection of intracranial tumors by combined assays of cfDNA methylation and other biomarkers. The study will enroll approximately 358 participants including intracranial malignant tumors, patients with benign disorders of central nervous system and healthy participants.

Enrollment: 358 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Cancer Participants:

• Age 40-75 years
• Ability to provide a written informed consent
• Pathologically confirmed diagnosis or highly suspicious cases of intracranial malignant tumors
• No prior or ongoing anti-cancer treatment (local or systematic) prior to study blood draw

Inclusion Criteria for Benign Disease Participants:

• Age 40-75 years
• Ability to provide a written informed consent
• Pathologically confirmed diagnosis or highly suspicious cases with benign disorders of central nervous system
• No prior or ongoing radical treatment of the benign disorders of central nervous system prior to study blood draw

Inclusion Criteria for Healthy Participants

• Age 40-75 years
• Ability to provide a written informed consent
• No cancer-related symptoms or other uncomfortable symptoms prior to study blood draw

Exclusion Criteria for All Participants:

• Insufficient qualified blood samples
• 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:

-Other current malignant diseases or multiple primary tumors

Additional Exclusion Criteria for Benign Disease Participants:

-Current or history of malignancies

Additional Exclusion Criteria for Healthy Participants:

• Recipient of anti-infectious therapy within 14 days prior to study blood draw
• Prior or ongoing treatment of cancer within 3 years prior to study blood draw
• Current autoimmune disease or clinically significant or uncontrolled comorbidities

Trial design

358 participants in 3 patient groups

Cancer Arm

Description:

Participants with newly diagnosed intracranial malignant tumors, from whom blood samples will be collected.

Treatment:

Device: early detection test

Benign Arm

Description:

Participants with newly diagnosed benign central nervous system disorders, from whom blood samples will be collected.

Treatment:

Device: early detection test

Healthy arm

Description:

Participants without known presence of malignancies or certain benign diseases, from whom blood samples will be collected.

Treatment:

Device: early detection test