Blood Cell RNA-Based Cancer Detection | NCT05839834

Studies
Blood Cell RNA-Based Cancer Detection

NCT05839834

Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Status

Recruiting

Last Update Posted

Jul 24, 2024Actual

Enrollment

5,000Estimated

Phase

Not provided

Conditions

Neoplasms
Cancer

Interventions

Blood 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

Jul 2024

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 8, 2021Actual

Primary Completion Date

Nov 1, 2024Estimated

Completion Date

Dec 8, 2024Estimated

First Submitted Date

Jul 12, 2022

First Submission Date that Met QC Criteria

Apr 20, 2023

First Posted Date

May 3, 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

Jul 22, 2024

Last Update Posted Date

Jul 24, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Zheng Wang, MD/PhD, Study chair, Clinical Professor, Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyPrincipal Investigator

Lead Sponsor

Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Early diagnosis of cancer may provide patients with more treatment options and hopefully prolong survival. The purpose of this multi-center study is to collect peripheral blood from newly diagnosed cancer patients and healthy donors to establish a blood cell RNA-based model for the differentiation of cancer patients and healthy donors. The area under the receiver operating characteristic (AUROC), sensitivity and specificity of the test in the early detection of multiple cancers will be measured.

Detailed Description

Not provided

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

Retention

Enrollment

5,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cancer		Patients with new diagnosis of cancers	Diagnostic Test: Blood test
Non-cancer		Healthy participants	Diagnostic Test: Blood test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood test	Diagnostic Test	RNA sequencing of peripheral blood cells	Cancer Non-cancer

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity and specificity of cancer detection	Sensitivity and specificity of the early detection of 30 types of cancers of a blood cell RNA-based cancer detection test	1 year
Accuracy of TOO prediction	Accuracy of the tissue of origin (TOO) prediction of a blood cell RNA-based cancer detection test	1 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria for All the Participants

Age 18 years or older
Provide informed consent

Exclusion Criteria for All the Participants:

Pregnancy or lactating women
Received a blood transfusion within 1 month
Received anti-cancer treatment within 3 years
Known prior diagnosis of cancer
Poor health status or unfit to tolerate blood draw

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Newly diagnosed cancer patients and healthy donors will be recruited from medical centers.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Zheng Wang, MD/PhD	Contact	+86 27 85726612		zhengwang@hust.edu.cn
Luming Xu	Contact	+86 27 85726612		lumingxu@hust.edu.cn

Overall Officials

Name	Affiliation	Role
Zheng Wang, MD/PhD	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zheng Wang	Recruiting	Wuhan	Hubei	430022	China

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
30106639	Background	Mellby LD, Nyberg AP, Johansen JS, Wingren C, Nordestgaard BG, Bojesen SE, Mitchell BL, Sheppard BC, Sears RC, Borrebaeck CAK. Serum Biomarker Signature-Based Liquid Biopsy for Diagnosis of Early-Stage Pancreatic Cancer. J Clin Oncol. 2018 Oct 1;36(28):2887-2894. doi: 10.1200/JCO.2017.77.6658. Epub 2018 Aug 14.
33506766	Background

ID	Term
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D008919	Investigative Techniques