Intracranial TumorsASCEND-BRAINNCT05679089
AssesSment of Early deteCtion basEd oN liquiD Biopsy in Intracranial Tumors
An observational study of Intracranial Tumors, run by Zhujiang Hospital at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 40 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Intracranial Tumors
- What is being tested?
- early detection test
- Type of treatment
- Medical device
- How many people
- 358 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 30 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhujiang Hospital
Guangzhou, Guangdong, 510280
Hongbo Guo, MD, Ph.D, 020-61643002, guohongbo911@126.com
About this study
Official title: Assessment of Early Detection Based on Liquid Biopsy in Intracranial Tumors: a Prospective Observational Study
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.
- Conditions
- Intracranial Tumors
- Being tested
- early detection test
- Keywords
- intracranial tumors, early detection, liquid biopsy, cell-free DNA methylation
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early detection testDevice
Blood collection and early detection testing
| Study group | Role | What they receive |
|---|---|---|
| Cancer Arm | Participants with newly diagnosed intracranial malignant tumors, from whom blood samples will be collected. Receives: Device: early detection test | |
| Benign Arm | Participants with newly diagnosed benign central nervous system disorders, from whom blood samples will be collected. Receives: Device: early detection test | |
| Healthy arm | Participants without known presence of malignancies or certain benign diseases, from whom blood samples will be collected. Receives: Device: early detection test |
What is being measured
The primary outcome is the main question the study is designed to answer.
The sensitivity and specificity of a cfDNA methylation-based early detection model for intracranial tumors.
Measured: 12 months
Secondary outcomes (1)
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start1 Nov 2022
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intracranial TumorsStudies of the same condition, open and under way.
- More trials run by Zhujiang HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 358 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhujiang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Hongbo Guo, MD,Ph.D, Principal investigator, Zhujiang Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05679089
- Sponsor's protocol ID
- RSCD2022009
- Acronym
- ASCEND-BRAIN
- Status last verified
- Dec 2022
- First submitted
- 28 Dec 2022
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Early Detection Based on Liquid Biopsy in Intracranial Tumors: a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05679089
- Acronym / sponsor ID
- ASCEND-BRAIN / RSCD2022009
- Conditions
- Intracranial Tumors
- Keywords
- intracranial tumors, early detection, liquid biopsy, cell-free DNA methylation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 358 participants (estimated)
- Lead sponsor
- Zhujiang HospitalUniversity, hospital or other
- Collaborators
- Guangzhou Burning Rock Dx Co., Ltd.
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 10 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cancer Arm | – | Device: early detection testParticipants with newly diagnosed intracranial malignant tumors, from whom blood samples will be collected. |
| Benign Arm | – | Device: early detection testParticipants with newly diagnosed benign central nervous system disorders, from whom blood samples will be collected. |
| Healthy arm | – | Device: early detection testParticipants without known presence of malignancies or certain benign diseases, from whom blood samples will be collected. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| early detection testBlood collection and early detection testing | Device | Benign Arm, Cancer Arm, Healthy arm |
Primary outcome
The sensitivity and specificity of a cfDNA methylation-based early detection model for intracranial tumors.
Time frame: 12 months
1 secondary outcome
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).
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hongbo Guo, MD,Ph.D principal investigator
Zhujiang Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intracranial Tumors, run by Zhujiang Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hongbo Guo, MD, Ph.D (020-61643002, guohongbo911@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The sensitivity and specificity of a cfDNA methylation-based early detection model for intracranial tumors. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.