Pan-canceR Early DetectIon projeCT (PREDICT)

NCT04817306 | Unknown DMC

• 1 other identifier: RSCD2020001
• Study Type: observational
• Target: 14,026
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Cancer

Keywords

Cancer; Cell-free DNA (cfDNA) methylation; Early detection

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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

Study Arms (3)

Cancer Arm

Participants with new diagnosis of cancer, from whom blood samples will be collected

Device: 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

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

Interventions

Multi-cancer early detection test DEVICE

Blood collection and multi-cancer early detection testing

Benign Diseases Arm; Cancer Arm; Non-tumor (Healthy) Arm

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Ability to provide a written informed consent
• years old

You may not qualify if:

• 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
• 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
• 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
• 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
• 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

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead
• Guangzhou Burning Rock Dx Co., Ltd.: collaborator

Study Sites (3)

Cancer Hospital, Chinese Academy of Medical Sciences & China National Cancer Center

Beijing, Beijing Municipality, 100021, China

NOT YET RECRUITING

Shanghai Ninth People's Hospital, Shanghai JiaoTong University, School of Medicine

Shanghai, Shanghai Municipality, 200011, China

NOT YET RECRUITING

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jia Fan, M.D., Ph.D

  Shanghai Zhongshan Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Qiang Gao, M.D.

CONTACT

+86 021 64041990; gao.qiang@zs-hospital.sh.cn

Shangli Cai, Ph.D

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 26, 2021
• Study Start: March 29, 2021
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2023
• Last Updated: March 30, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)