Clinical trial NCT05679089: AssesSment of Early deteCtion basEd oN liquiD Biopsy in Intracranial Tumors
Official title: Assessment of Early Detection Based on Liquid Biopsy in Intracranial Tumors: a Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intracranial Tumors
Keywords: intracranial tumors, early detection, liquid biopsy, cell-free DNA methylation
Lead sponsor: Zhujiang Hospital
Sponsor class: OTHER
Collaborators: name: Guangzhou Burning Rock Dx Co., Ltd.
First posted: 2023-01-10
Enrollment: 358
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


Eligibility 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

Primary outcomes:
measure: The sensitivity and specificity of a cfDNA methylation-based early detection model for intracranial tumors.
timeFrame: 12 months
Secondary outcomes:
measure: 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).
timeFrame: 12 months
Other outcomes:
measure: The specific cfDNA methylation landscape of intracranial tumors in China
timeFrame: 12 months
Locations:
city: Guangzhou
country: China
facility: Zhujiang Hospital
state: Guangdong
Study officials:
affiliation: Zhujiang Hospital
name: Hongbo Guo, MD,Ph.D
role: PRINCIPAL_INVESTIGATOR
References: