Pan-canceR Early DetectIon projeCT (PREDICT)

A Prospective, Multicenter Study on Development and Validation of the Performance of a cfDNA Methylation-based Model for Early Cancer Detection (Pan-canceR Early DetectIon projeCT, PREDICT Study)

PREDICT is a prospective, multicenter study for the early detection of pan-cancer through cell-free DNA (cfDNA) methylation-based model, in which approximately 14,000 participants will be enrolled. The development and validation of the model will be conducted in participants with cancers or benign diseases, along with non-tumor (healthy) individuals through a two-stage approach. The sensitivity and specificity of the model in cancer early detection will be evaluated, and the accuracy of the identification for tissue of origin will be obtained.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 14026

Contacts and Locations

• Study Contact: Name: Qiang Gao, M.D.; Phone Number: +86 021 64041990; Email: gao.qiang@zs-hospital.sh.cn
• 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
      • Not yet recruiting
      • Cancer Hospital, Chinese Academy of Medical Sciences & China National Cancer Center
      • Contact: Zhijie Wang, M.D.; Phone Number: +86-010-67781331
      • Principal Investigator: Jie Wang, M.D., Ph.D
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Qiang Gao, M.D.; Phone Number: +86-021 64041990; Email: gao.qiang@zs-hospital.sh.cn
      • Principal Investigator: Jia Fan, M.D., Ph.D
    • Shanghai, Shanghai, China, 200011
      • Not yet recruiting
      • Shanghai Ninth People's Hospital, Shanghai JiaoTong University, School of Medicine
      • Contact: Xi Yang, M.D.; Phone Number: +86-021-23271699
      • Principal Investigator: Chenping Zhang, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Eligible participants will be recruited from medical centers and assigned into three arms, including participants with new diagnosis of cancer 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 of a cancer or highly suspicious cases of cancer within 42 days prior to study blood draw. Tumor types in this study include lung cancer, colorectal cancer, liver cancer, ovarian cancer, gastric cancer, esophageal cancer, pancreatic cancer, biliary tract cancer, squamous cell carcinoma of the head and neck (except nasopharyngeal carcinoma)
• 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:

• Histopathologically confirmed or highly suspicious for benign diseases corresponding to the tumor types in the Cancer Arm within 90 days prior to study blood draw, or highly suspicious for benign diseases corresponding to the tumor types in Cancer Arm by radiological assessments or other clinical examinations
• No prior treatment of benign disease prior to study blood draw

Exclusion Criteria for Benign Diseases Arm Participants:

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

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 abdominal ultrasound
• No clinically significant finding by breast ultrasound or Molybdenum Target Mammography Detection, or cervical liquid-based cell (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
• Unexplained weight loss
• Prior or current major diseases, including COPD, interstitial pneumonia, viral hepatitis, liver cirrhosis, inflammatory bowel disease
• Prior and current adenoma of the intestine and polyp of the intestine
• Changes in bowel habits, bowel abnormalities, hematochezia within 30 days prior to study blood draw
• Uncontrolled hypertension and other cardiovascular diseases
• Currently severe bleeding disorders
• Major surgery within 24 weeks prior to study blood draw
• Infection requiring anti-microbial therapy within 24 weeks prior to study blood draw
• Current autoimmunity disease
• Clinically significant or uncontrolled comorbidities which, in the investigator's opinion, should be excluded

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 testing
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 testing
Non-tumor (Healthy) Arm; Participants without known presence of malignancies or benign diseases, from whom blood samples will be collected	Device: Multi-cancer early detection test; Blood collection and multi-cancer early detection testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Sensitivity of early detection of cancer and Tissue of origin (TOO) accuracy of a cfDNA methylation-based model when specificity is 90%, 95% or 98% in healthy participants	24 months
Sensitivity and specificity of early detection of cancer and TOO accuracy of a cfDNA methylation-based model	24 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in various types of cancer	24 months
Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model in different stages of cancer	24 months
Sensitivity, specificity and TOO accuracy of a cfDNA methylation-based model, in combination with clinical characteristics and other biomarkers	24 months

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital
• Collaborators: Guangzhou Burning Rock Dx Co., Ltd.
• Investigators: Principal Investigator: Jia Fan, M.D., Ph.D, Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 23, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): March 30, 2021
• Last Update Submitted That Met QC Criteria: March 29, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: Cancer; Early detection; Cell-free DNA (cfDNA) methylation
• Other Study ID Numbers: RSCD2020001

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