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Trial Title:
AssesSment of Early deteCtion basEd oN liquiD Biopsy in Intracranial Tumors
NCT ID:
NCT05679089
Condition:
Intracranial Tumors
Conditions: Official terms:
Brain Neoplasms
Conditions: Keywords:
intracranial tumors, early detection, liquid biopsy, cell-free DNA methylation
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
early detection test
Description:
Blood collection and early detection testing
Arm group label:
Benign Arm
Arm group label:
Cancer Arm
Arm group label:
Healthy arm
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
All
Minimum age:
40 Years
Maximum age:
75 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Zhujiang Hospital
Address:
City:
Guangzhou
Zip:
510280
Country:
China
Status:
Recruiting
Contact:
Last name:
Hongbo Guo, MD, Ph.D
Phone:
020-61643002
Email:
guohongbo911@126.com
Start date:
November 1, 2022
Completion date:
June 30, 2024
Lead sponsor:
Agency:
Zhujiang Hospital
Agency class:
Other
Collaborator:
Agency:
Guangzhou Burning Rock Dx Co., Ltd.
Agency class:
Industry
Source:
Zhujiang Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05679089
