Intracranial Tumors
Conditions
Keywords
intracranial tumors, early detection, liquid biopsy, cell-free DNA methylation
Brief 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.
Interventions
DEVICEearly detection test
Blood collection and early detection testing
Sponsors
Guangzhou Burning Rock Dx Co., Ltd.
Zhujiang Hospital
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The sensitivity and specificity of a cfDNA methylation-based early detection model for intracranial tumors. | 12 months |
Secondary
| 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
| Measure | Time frame |
|---|---|
| The specific cfDNA methylation landscape of intracranial tumors in China | 12 months |
Countries
China
Contacts
Primary ContactHongbo Guo, MD, Ph.D
Backup ContactBoyang Liu, MD
Outcome results
None listed