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

Assessment of Early Detection Based on Liquid Biopsy in Intracranial Tumors: a Prospective Observational Study

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 358

Contacts and Locations

• Study Contact: Name: Hongbo Guo, MD, Ph.D; Phone Number: 020-61643002; Email: guohongbo911@126.com
• Study Contact Backup: Name: Boyang Liu, MD; Phone Number: 020-62787841; Email: lby19881118@163.com

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510280
      • Recruiting
      • Zhujiang Hospital
      • Contact: Hongbo Guo, MD, Ph.D; Phone Number: 020-61643002; Email: guohongbo911@126.com

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 three arms, including participants with newly diagnosed intracranial malignant tumors, benign disorders of central nervous system and healthy participants.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cancer Arm; Participants with newly diagnosed intracranial malignant tumors, from whom blood samples will be collected.	Device: early detection test; Blood collection and early detection testing
Benign Arm; Participants with newly diagnosed benign central nervous system disorders, from whom blood samples will be collected.	Device: early detection test; Blood collection and early detection testing
Healthy arm; Participants without known presence of malignancies or certain benign 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 a cfDNA methylation-based early detection model for intracranial tumors.	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The sensitivity and specificity of a cfDNA methylation-based early detection model for intracranial tumors of different grades(WHO I-IV) and mutant subtypes(IDH mutant/wild type).	12 months

Other Outcome Measures

Outcome Measure	Time Frame
The specific cfDNA methylation landscape of intracranial tumors in China	12 months

Collaborators and Investigators

• Sponsor: Zhujiang Hospital
• Collaborators: Guangzhou Burning Rock Dx Co., Ltd.
• Investigators: Principal Investigator: Hongbo Guo, MD,Ph.D, Zhujiang Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: December 28, 2022
• First Submitted That Met QC Criteria: December 28, 2022
• First Posted (Estimate): January 10, 2023

Study Record Updates

• Last Update Posted (Estimate): January 10, 2023
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: intracranial tumors, early detection, liquid biopsy, cell-free DNA methylation
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Neoplasms by Site; Central Nervous System Neoplasms; Nervous System Neoplasms; Brain Neoplasms
• Other Study ID Numbers: RSCD2022009

Drug and device information, study documents

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