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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05679089
Other study ID # RSCD2022009
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Completed NCT02431572 - A Pilot Study to Evaluate PBR PET in Brain Tumor Patients Treated With Chemoradiation or Immunotherapy N/A