AssesSment of Early deteCtion basEd oN liquiD Biopsy in Intracranial Tumors

Intracranial Tumors Clinical Trial

— ASCEND-BRAIN  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05679089
• Other study ID #: RSCD2022009
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2022
• Source: Zhujiang Hospital
• Contact: Hongbo Guo, MD, Ph.D
• Phone: 020-61643002
• Email: guohongbo911[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 358
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Intracranial Tumors

Intervention

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

Locations

Country	Name	City	State
China	Zhujiang Hospital	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Zhujiang Hospital	Guangzhou Burning Rock Dx Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	The specific cfDNA methylation landscape of intracranial tumors in China		12 months
Primary	The sensitivity and specificity of a cfDNA methylation-based early detection model for intracranial tumors.		12 months
Secondary	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