NCT06790355

Brief Summary

This is a prospective, multi-centre interventional study evaluating the feasibility of blood-based multi-cancer early detection test in asymptomatic screening cohort.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,527

participants targeted

Target at P75+ for not_applicable lung-cancer

Timeline
Completed

Started Mar 2025

Geographic Reach
1 country

4 active sites

Status
completed

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

First Submitted

Initial submission to the registry

January 12, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 24, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2026

Completed
Last Updated

September 4, 2026

Status Verified

September 1, 2026

Enrollment Period

1.5 years

First QC Date

January 12, 2025

Last Update Submit

September 1, 2026

Conditions

Lung CancerColorectal CancerLiver CancerGrastic CancerEsophageal Cancer

Keywords

multi-cancer early detectionMCEDcancer screeningcirculating cell-free tumor DNAmethylation

Outcome Measures

Primary Outcomes (2)

  • Feasibility of MCED in the intended use setting.

    Descriptive statistics will be used to summarize the number of 5 pre-specified cancers diagnosed by MCED.

    From enrollment to the Follow-up at 1 year

  • Safety of MCED in the intended use setting.

    Descriptive statistics will be used to summarize the time to achieve diagnostic resolution following receipt of a positive MCED test and to assess the extent of testing pursued.

    From enrollment to the Follow-up at 1 year

Secondary Outcomes (5)

  • Performance of MCED in the intended use setting.

    From enrollment to the Follow-up at 1 year

  • Cancer signal origin accuracy of MCED.

    From enrollment to the Follow-up at 1 year

  • Clinical utility of MCED alongside SOC screening.

    From enrollment to the Follow-up at 1 year

  • Participant-reported psychological impact.

    From enrollment to the Follow-up at 1 year

  • Participant-reported health related quality of life (HRQoL) .

    From enrollment to the Follow-up at 1 year

Other Outcomes (2)

  • Participant-reported satisfaction with MCED.

    From enrollment to the Follow-up at 1 year

  • Cross-reactivity of MCED.

    From enrollment to the Follow-up at 1 year

Study Arms (1)

Healthy subjects

EXPERIMENTAL
Device: multi-cancer early detection

Interventions

multi-cancer early detectionDEVICE

Blood collection for multi-cancer early detection（MCED）, followed by clinical diagnosis based on the results of MCED and standard-of-care screening

Healthy subjects

Eligibility Criteria

Age40 Years - 74 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old
  • Able to provide a written informed consent and willing to comply with all parts of the protocol procedures

You may not qualify if:

  • With cancer-associated clinical symptoms or suspected of cancer within 30 days prior to screen
  • Have definite contraindications of cancer screening examination and diagnostic procedures
  • Unable to comply with the protocol procedures
  • Personal history of cancer, diagnosed within the 3 years prior to expected enrollment date
  • Recipients of anti-tumor therapy within 30 days prior to screen
  • Pregnancy or lactating women
  • Recipients of organ transplant or prior bone marrow transplant or stem cell transplant
  • Recipients of blood transfusion within 7 days prior to screen
  • With autoimmune diseases
  • Have an acute infection or inflammation or uncontrolled chronic infection within 14 days prior to blood draw
  • Unsuitable for this trial determined by the researchers (eg. hemorrhagic diseases)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Fujian Cancer Hospital

Fuzhou, Fujian, 350014, China

Location

Henan Cancer Hospital

Zhengzhou, Henan, 450008, China

Location

Jiangsu Cancer Hospital

Nanjing, Jiangsu, 210009, China

Location

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

Location

MeSH Terms

Conditions

Lung NeoplasmsColorectal NeoplasmsLiver NeoplasmsEsophageal Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract DiseasesIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal DiseasesLiver DiseasesHead and Neck NeoplasmsEsophageal Diseases

Study Officials

  • Xianjun Yu

    Fudan University

    PRINCIPAL INVESTIGATOR

  • Xiaohui Wu

    Shanghai Weihe Medical Laboratory Co., Ltd.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2025

First Posted

January 24, 2025

Study Start

March 1, 2025

Primary Completion

August 31, 2026

Study Completion

August 31, 2026

Last Updated

September 4, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations

CN(4)