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

Cancer Clinical Trial

— PRESCIENT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04822792
• Other study ID #: RSCD2020002
• Status: Recruiting
• Start date: March 23, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2021
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Jiachen Xu, M.D.
• Phone: +86-010-87788029
• Email: XJCwelcome[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 11879
• Est. completion date: June 30, 2023
• Est. primary completion date: March 31, 2023
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Device:
• Multi-cancer early detection test
Blood collection and multi-cancer early detection test

Locations

Country	Name	City	State
China	Cancer Hospital Chinese Academy of Medical Sciences	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Guangzhou Burning Rock Dx Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Sensitivity and specificity of a cfDNA methylation-based model combined with serum tumor markers in participants with cancers or benign diseases		22 months
Secondary	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
Secondary	Sensitivity and specificity of early detection of cancer in different stages		22 months