AssesSment of Early deteCtion basEd oN liquiD Biopsy in Intracranial Tumors

NCT ID: NCT05679089

Last Updated: 2023-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

358 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2024-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Intracranial Tumors

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cancer Arm

Participants with newly diagnosed intracranial malignant tumors, from whom blood samples will be collected.

early detection test

Intervention Type DEVICE

Blood collection and early detection testing

Benign Arm

Participants with newly diagnosed benign central nervous system disorders, from whom blood samples will be collected.

early detection test

Intervention Type DEVICE

Blood collection and early detection testing

Healthy arm

Participants without known presence of malignancies or certain benign diseases, from whom blood samples will be collected.

early detection test

Intervention Type DEVICE

Blood collection and early detection testing

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

early detection test

Blood collection and early detection testing

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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


* 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


* 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

* 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)


-Other current malignant diseases or multiple primary tumors


-Current or history of malignancies


* 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
Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Guangzhou Burning Rock Dx Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Zhujiang Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hongbo Guo, MD,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Zhujiang Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhujiang Hospital

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Hongbo Guo, MD, Ph.D

Role: CONTACT

020-61643002

Boyang Liu, MD

Role: CONTACT

020-62787841

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Hongbo Guo, MD, Ph.D

Role: primary

020-61643002

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RSCD2022009

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Taiwan Cancer Moonshot Project
NCT05248763 RECRUITING