The Unintrusive Detection of EaRly-stage Cancers | NCT04820868

Studies
The Unintrusive Detection of EaRly-stage Cancers

NCT04820868

Sponsor

Shanghai Zhongshan Hospital

Status

Completed

Last Update Posted

Mar 16, 2023Actual

Enrollment

2,508Actual

Phase

Not provided

Conditions

Cancer

Interventions

Multi-cancer 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

Mar 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 23, 2021Actual

Primary Completion Date

Nov 30, 2021Actual

Completion Date

Apr 30, 2022Actual

First Submitted Date

Mar 26, 2021

First Submission Date that Met QC Criteria

Mar 26, 2021

First Posted Date

Mar 29, 2021Actual

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

Mar 14, 2023

Last Update Posted Date

Mar 16, 2023Actual

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

Description Module

Brief Summary

According to a previous study, a cell-free DNA (cfDNA) methylation-based model showed high sensitivity and specificity (80.6% and 98.3%) in blood-based multi-cancer detection. In this way, a multi-center, prospective, single-blind study (THUNDER study) is designed to further validate the performance of the cfDNA methylation-based model for early cancer detection. Blood RNA markers will also be evaluated. The study will enroll approximately 2508 participants, including participants with malignancies and healthy participants.

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

No data available

No data is available for this block.

Enrollment

2,508Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Cancer Arm		Participants with new diagnosis of cancer, from whom blood samples will be collected	Device: Multi-cancer early detection test
Healthy Arm		Participants without known presence of malignancies or benign diseases, from whom blood samples will be collected	Device: Multi-cancer early detection test

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multi-cancer early detection test	Device	Blood collection and multi-cancer early detection test	Cancer Arm Healthy Arm

Measure	Description	Time Frame
Sensitivity and specificity of early detection of 6 types of cancers and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model		7 months

Measure	Description	Time Frame
Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in different stages or pathological types of cancer		7 months

Eligibility Module

Eligibility Criteria

Inclusion Criteria for All the Participants:

Ability to provide a written informed consent
40-75 years old
Ability to comply with study procedures

Exclusion Criteria for All the Participants:

Pregnancy or lactating women
Recipients of organ transplant or prior non-autologous (allogeneic) bone marrow transplant or stem cell transplant
Recipients of blood transfusion within 7 days prior to study blood draw
Recipients of any anti-cancer therapy within 30 days prior to study blood draw, due to diseases other than cancer

Inclusion Criteria for Cancer Arm Participants:

Confirmed diagnosis or suspicious cases of cancer within 42 days prior to study blood draw.
No prior anti-cancer therapy (local or systematic) prior to study blood draw

Exclusion Criteria for Cancer Arm Participants:

Known prior or current diagnosis of other types of malignancies or multiple primary tumors
Diagnosis of benign diseases by histopathological assessments
No confirmed diagnosis of cancer by histopathological or radiological assessments within 42 days of study blood draw, or inability to characterize whether the lesion is malignant or benign
Non-small-cell lung cancer patients with ground-class nodularity by radiological examination
Diagnosis of precancerous lesions

Inclusion Criteria for Healthy Arm Participants:

No cancer-related symptoms or discomfort within 30 days prior to study blood draw
No clinically significant finding by physical examinations, hematological assessment, urinalysis, LDCT or ultrasound
No clinically significant finding by breast ultrasound or Molybdenum Target Mammography Detection, or Thinprep cytologic test (TCT) detection for female participants
No active hepatitis B or hepatitis C infection

Exclusion Criteria for Healthy Arm Participants:

Prior or ongoing treatment of cancer within 3 years prior to study blood draw
Clinically significant or uncontrolled comorbidities

Accepts Healthy Volunteers

Not provided

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 medical centers and assigned into two arms, including participants with new diagnosis of malignancies and healthy participants.

Sampling Method

Non-Probability Sample