NCT05679089

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
358

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

January 10, 2023

Status Verified

December 1, 2022

Enrollment Period

1.2 years

First QC Date

December 28, 2022

Last Update Submit

December 28, 2022

Conditions

Intracranial Tumors

Keywords

intracranial tumors, early detection, liquid biopsy, cell-free DNA methylation

Outcome Measures

Primary Outcomes (1)

  • The sensitivity and specificity of a cfDNA methylation-based early detection model for intracranial tumors.

    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).

    12 months

Other Outcomes (1)

  • The specific cfDNA methylation landscape of intracranial tumors in China

    12 months

Study Arms (3)

Cancer Arm

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

Device: early detection test

Benign Arm

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

Device: early detection test

Healthy arm

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

Device: early detection test

Interventions

early detection testDEVICE

Blood collection and early detection testing

Benign ArmCancer ArmHealthy arm

Eligibility Criteria

Age40 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Zhujiang Hospital

Guangzhou, Guangdong, 510280, China

RECRUITING

MeSH Terms

Conditions

Brain Neoplasms

Condition Hierarchy (Ancestors)

Central Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Hongbo Guo, MD,Ph.D

    Zhujiang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hongbo Guo, MD, Ph.D

CONTACT

020-61643002guohongbo911@126.com

Boyang Liu, MD

CONTACT

020-62787841lby19881118@163.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 28, 2022

First Posted

January 10, 2023

Study Start

November 1, 2022

Primary Completion

December 31, 2023

Study Completion

June 30, 2024

Last Updated

January 10, 2023

Record last verified: 2022-12

Locations

CN(1)