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

NCT04822792 | Unknown DMC

• 1 other identifier: RSCD2020002
• Study Type: observational
• Target: 11,879
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

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

Healthy Arm

Participants without known presence of malignancies or benign disease, 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 test

Benign Diseases Arm; Cancer Arm; Healthy Arm

Eligibility Criteria

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

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 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
• 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
• 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
• History of malignancies
• Current malignancies or precancerous lesions

Sponsors & Collaborators

• Cancer Institute and Hospital, Chinese Academy of Medical Sciences: lead
• Guangzhou Burning Rock Dx Co., Ltd.: collaborator

Study Sites (1)

Cancer Hospital Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jie Wang, M.D., Ph.D

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiachen Xu, M.D.

CONTACT

+86-010-87788029; XJCwelcome@126.com

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 29, 2021
• First Posted: March 30, 2021
• Study Start: March 23, 2021
• Primary Completion: March 31, 2023
• Study Completion: June 30, 2023
• Last Updated: June 2, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)