Pan-canceR Early-Stage deteCtion by lIquid Biopsy tEchNique projecT

Pan-cancer Early-stage Detection by Liquid Biopsy in Peripheral Blood: a Multi-center, Prospective Observational Study

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04822792

Acronym

PRESCIENT

Enrollment

11879

Registered

2021-03-30

Start date

2021-03-23

Completion date

2023-06-30

Last updated

2021-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

Cancer, Liquid biopsy, Cell-free DNA (cfDNA), Early detection

Brief summary

PRESCIENT is a multi-center, prospective observational study aimed to detect cancers early by combined assays for serum protein markers and cell-free DNA (cfDNA) methylation markers. Blood RNA markers will also be evaluated. The study will enroll approximately 11879 participants, including participants with malignancies or benign diseases, and healthy participants.

Interventions

DEVICEMulti-cancer early detection test

Blood collection and multi-cancer early detection test

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

Inclusion criteria

for All the Participants: * Ability to provide a written informed consent * 40-75 years old

Exclusion criteria

for All the Participants: * Inability to comply with study procedures * 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 one of the 22 types of malignancies within 42 days prior to study blood draw * No prior or ongoing anti-cancer therapy (local or systematic) prior to study blood draw

Design outcomes

Primary

Measure	Time frame
Sensitivity and specificity of early detection of 22 types of cancers and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model, in combination with serum tumor markers	22 months

Secondary

Measure	Time frame
Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in participants with cancers or benign diseases	22 months
Sensitivity and specificity of serum tumor markers, cfDNA methylation-based model, and a cfDNA methylation-based model combined with serum tumor markers, in participants with cancers and healthy participants	22 months
Sensitivity and specificity of early detection of cancer in different stages	22 months

Countries

China

Contacts

Primary ContactJiachen Xu, M.D.

XJCwelcome@126.com+86-010-87788029

Backup ContactShangli Cai, Ph.D.

shangli.cai@brbiotech.com+86-021-61631938

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026