Pan-canceR Early-Stage deteCtion by lIquid Biopsy tEchNique projecT (PRESCIENT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer
• Intervention / Treatment: Device: Multi-cancer early detection test

• Study Type: Observational
• Enrollment (Anticipated): 11879

Contacts and Locations

• Study Contact: Name: Jiachen Xu, M.D.; Phone Number: +86-010-87788029; Email: XJCwelcome@126.com
• Study Contact Backup: Name: Shangli Cai, Ph.D.; Phone Number: +86-021-61631938; Email: shangli.cai@brbiotech.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Sciences
      • Principal Investigator: Jie Wang, M.D., Ph.D
      • Contact: Jiachen Xu, M.D.; Phone Number: +86-10-87788029; Email: XJCwelcome@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be re recruited from medical centers and assigned into three arms, including participants with new diagnosis of malignancies or corresponding benign diseases, and participants without the presence of malignancies or benign diseases.

Description

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

Exclusion Criteria for Cancer Arm Participants:

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

Inclusion Criteria for Benign Diseases Arm Participants:

• Confirmed diagnosis of benign diseases corresponding to the tumor types in the Cancer Arm by histopathological or radiological assessments within 90 days prior to study blood draw
• No prior treatment of benign diseases prior to study blood draw

Exclusion Criteria for Benign Diseases Arm Participants:

• History of malignancies
• Current malignancies or precancerous lesions
• No confirmed diagnosis of a benign disease by radiological, endoscopic or histopathological assessments within 42 days of study blood draw, or inability to characterize whether the lesion is malignant or benign

Inclusion Criteria for Non-tumor (Healthy) Arm Participants:

• No cancer-related symptoms or discomfort within 30 days prior to study blood draw
• No clinically significant finding by 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 Non-tumor (Healthy) Arm Participants:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cancer Arm; Participants with new diagnosis of cancer, from whom blood samples will be collected	Device: Multi-cancer early detection test; Blood collection and multi-cancer early detection test
Benign Diseases Arm; Participants with benign diseases corresponding to the tumor types in the Cancer Arm, from whom blood samples will be collected	Device: Multi-cancer early detection test; Blood collection and multi-cancer early detection test
Healthy Arm; Participants without known presence of malignancies or benign disease, from whom blood samples will be collected	Device: Multi-cancer early detection test; Blood collection and multi-cancer early detection test

What is the study measuring?

Primary Outcome Measures

Outcome 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 Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Collaborators: Guangzhou Burning Rock Dx Co., Ltd.
• Investigators: Principal Investigator: Jie Wang, M.D., Ph.D, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 23, 2021
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: March 29, 2021
• First Submitted That Met QC Criteria: March 29, 2021
• First Posted (Actual): March 30, 2021

Study Record Updates

• Last Update Posted (Actual): June 2, 2021
• Last Update Submitted That Met QC Criteria: May 29, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Cancer; Liquid biopsy; Early detection; Cell-free DNA (cfDNA)
• Other Study ID Numbers: RSCD2020002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No