Pan-canceR Early DetectIon projeCT (PREDICT)

Burning Rock Pan-canceR Early DetectIon projeCT (PREDICT): a Prospective, Multicenter Study to Develop and Validate the Performance of a cfDNA Methylation Based Model on Early Cancer Detection

PREDICT is a prospective, multi-center 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 early stage 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: Not yet recruiting
• Conditions: Cancer

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

Contacts and Locations

• Study Contact: Name: Customer Service Burning Rock; Phone Number: 400-689-7600; Email: info@brbiotech.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
      • 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
      • Zhongshan Hospital, Fudan University
      • Principal Investigator: Jia Fan, M.D., Ph.D
      • Contact: Qiang Gao, M.D.; Phone Number: +86-021 64041990; Email: ec@zs-hospital.sh.cn
    • Shanghai, Shanghai, China, 200011
      • 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 malignancy or corresponding benign disease, and participants without the presence of malignant or benign diseases.

Description

Inclusion Criteria for Cancer Arm Participants:

• Able to provide a written informed consent.
• Able to provide sufficient and qualified blood samples for study tests.
• No prior or undergoing cancer treatment (local or systematic) with either of the following:
• A. Pathologically confirmed cancer diagnosis within 30 (±7) days prior to the study blood draw.
• B. High suspicious for cancer diagnosis by radiological or other routine clinical assessments, with confirmed cancer diagnosis through biopsy or surgical resection within 36 (±7) days after study blood draw.

Exclusion Criteria for Cancer Arm Participants:

• Insufficient qualified blood sample for study test.
• During pregnancy or lactation.
• Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
• Recipient of blood transfusion within 30 days prior to study blood draw.
• With other known malignant tumors or multiple primary tumors.

Inclusion Criteria for Benign Disease Arm Participants:

• Able to provide a written informed consent.
• Able to provide sufficient and qualified blood samples for study tests.
• Have either of the following:
• A. Pathological confirmed diagnosis of benign diseases within 90 (±7) days prior to the study blood draw, with no prior treatment such as surgical resection.
• B. High suspicious for benign diseases diagnosis by radiological or other routine clinical assessments, with confirmed benign diseases diagnosis within 36 (±7) days after study blood draw.

Exclusion Criteria for Benign Disease Arm Participants:

• Insufficient qualified blood sample for study test.
• During pregnancy or lactation.
• Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
• Recipient of blood transfusion within 30 days prior to study blood draw.

Inclusion Criteria for Non-Tumor Arm Participants:

• Able to provide a written informed consent.
• Able to provide sufficient and qualified blood samples for study tests.
• No cancer related symptoms within 30 days prior to study screening.
• Cancer history with curative treatment completed over 3 years without recurrence prior to study enrollment.

Exclusion Criteria for Non-Tumor Arm Participants:

• Insufficient qualified blood sample for study test.
• During pregnancy or lactation.
• Recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant.
• Recipient of blood transfusion within 30 days prior to study blood draw.
• Recipient of anti-infectious therapy within 14 days prior to study blood draw.
• Have received or are undergoing curative cancer treatment within three years prior to study screening.
• With autoimmune or other diseases with severe 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
Cancer arm; Participants with new diagnosis of cancer, from whom a blood sample and contemporaneous tissue samples will be collected.
Benign disease arm; Participants with benign diseases corresponding to the tumor types in the cancer arm, from whom a blood sample and contemporaneous tissue samples will be collected.
Non-tumor arm (Healthy); Participants with no known presence of malignancies or benign diseases, from whom a blood sample will be collected.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The cfDNA methylations profiles of patients with malignancies or benign diseases using pre-treatment biospecimens.	32 months
The sensitivity and specificity of multi-cancer early detection and the accuracy of TOO identification via cfDNA methylation based model.	32 months

Secondary Outcome Measures

Outcome Measure	Time Frame
The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in pre-specified subgroups.	32 months
The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in combination with clinicopathological characteristics or other biomarkers.	32 months
The examinations related to cancer diagnosis from the participants who were identified as positive cases by cfDNA methylation based model while as healthy individuals by routine medical examinations.	32 months
The sensitivity and specificity of cancer early detection and the accuracy of TOO identification via cfDNA methylation based model in the independent training and validation sets.	32 months

Collaborators and Investigators

• Sponsor: Guangzhou Burning Rock Dx Co., Ltd.
• Investigators: Study Director: Hao Liu, M.D, Guangzhou Burning Rock Dx Co., Ltd.

Publications and helpful links

General Publications

• Luo B, Ma F, Liu H, Hu J, Rao L, Liu C, Jiang Y, Kuangzeng S, Lin X, Wang C, Lei Y, Si Z, Chen G, Zhou N, Liang C, Jiang F, Liu F, Dai W, Liu W, Gao Y, Li Z, Li X, Zhou G, Li B, Zhang Z, Nian W, Luo L, Liu X. Cell-free DNA methylation markers for differential diagnosis of hepatocellular carcinoma. BMC Med. 2022 Jan 14;20(1):8. doi: 10.1186/s12916-021-02201-3.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 21, 2020
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): March 1, 2023

Study Registration Dates

• First Submitted: May 7, 2020
• First Submitted That Met QC Criteria: May 7, 2020
• First Posted (Actual): May 12, 2020

Study Record Updates

• Last Update Posted (Actual): July 22, 2020
• Last Update Submitted That Met QC Criteria: July 20, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: early detection; cancer; 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