AssesSment of Early deteCtion basEd oN liquiD Biopsy in I... | NCT05679089

Studies
AssesSment of Early deteCtion basEd oN liquiD Biopsy in Intracranial Tumors

NCT05679089

Sponsor

Zhujiang Hospital

Status

Unknown status

Last Update Posted

Jan 10, 2023Actual

Enrollment

358Estimated

Phase

Not provided

Conditions

Intracranial Tumors

Interventions

early detection test

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 1, 2022Actual

Primary Completion Date

Dec 31, 2023Estimated

Completion Date

Jun 30, 2024Estimated

First Submitted Date

Dec 28, 2022

First Submission Date that Met QC Criteria

Dec 28, 2022

First Posted Date

Jan 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 28, 2022

Last Update Posted Date

Jan 10, 2023Actual

Name	Class
Guangzhou Burning Rock Dx Co., Ltd.	INDUSTRY

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

358Estimated

Arms/Interventions Module

Arm Groups

Label	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
early detection test	Device	Blood collection and early detection testing	Benign Arm Cancer Arm Healthy arm

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

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

Measure	Description	Time Frame
The specific cfDNA methylation landscape of intracranial tumors in China		12 months

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

75 Years

Standard Ages

AdultOlder 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.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Hongbo Guo, MD, Ph.D	Contact	020-61643002		guohongbo911@126.com
Boyang Liu, MD	Contact	020-62787841		lby19881118@163.com

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms