AssesSment of Early deteCtion basEd oN liquiD Biopsy in Intracranial Tumors

Study Overview
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Brief Summary
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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.

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

Conditions
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Intracranial Tumors

Intervention / Treatment
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* Device: early detection test


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cancer Arm<br>Participants with newly diagnosed intracranial malignant tumors, from whom blood samples will be collected. | Device: early detection test<br>* Blood collection and early detection testing<br>|
| Benign Arm<br>Participants with newly diagnosed benign central nervous system disorders, from whom blood samples will be collected. | Device: early detection test<br>* Blood collection and early detection testing<br>|
| Healthy arm<br>Participants without known presence of malignancies or certain benign diseases, from whom blood samples will be collected. | Device: early detection test<br>* Blood collection and early detection testing<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity and specificity of a cfDNA methylation-based early detection model for intracranial tumors. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intracranial tumors, early detection, liquid biopsy, cell-free DNA methylation