A Proof of Concept Study of Pan-cancer Early Detection by Liquid Biopsy

Cancer Clinical Trial

— PROMISE  

Official title:

The Performance of a Pan-cancer Early Detection Model Based on Liquid Biopsy of Various-omics Biomarkers: a Proof of Concept Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04972201
• Other study ID #: RSCD2020006
• Status: Recruiting
• Start date: July 5, 2021
• Est. completion date: March 31, 2022

Study information

• Verified date: July 2021
• Source: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Contact: Jiachen Xu, M.D.
• Phone: +86-10-87788029
• Email: XJCwelcome[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

PROMISE is a multi-center, prospective and proof of concept study aimed to evaluate the performance of 3 prototype assays of cell-free DNA (cfDNA) mutation, cfDNA methylation and microRNA (miRNA) expression in early detection of multi-cancer. Assay(s) will be selected for further development. The study will enroll approximately 2035 participants, including participants with cancers and healthy participants.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2305
• Est. completion date: March 31, 2022
• Est. primary completion date: December 31, 2021
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

Inclusion Criteria for Cancer Arm Participants:

• Ability to provide a written informed consent
• 40-75 years old
• Ability to comply with study procedures
• Confirmed diagnosis or suspicious cases of one of the 9 types of cancers within 42 days prior to study blood draw.
• No prior anti-cancer therapy (local or systematic) prior to study blood draw

Exclusion Criteria for Cancer Arm Participants:

• 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
• 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 or precancerous lesions by histopathological assessments, or inability to characterize whether the lesion is malignant or benign

Inclusion Criteria for Healthy Arm Participants:

• Ability to provide a written informed consent
• 40-75 years old
• No cancer-related symptoms or discomfort within 30 days prior to study blood draw
• Ability to comply with study procedures
• No clinically significant finding by laboratory tests and radiology examinations

Exclusion Criteria for Healthy Arm Participants:

• 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
• Clinically significant or uncontrolled comorbidities
• Prior or ongoing treatment of cancer within 3 years prior to study blood draw

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 Institute and Hospital, Chinese Academy of Medical Sciences	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 of early detection of cancers and Tissue of origin (TOO) accuracy of 3 assays of cfDNA mutation, cfDNA methylation and miRNA expression when specificity was 90%, 95% or 98% in healthy participants		9 months
Secondary	Sensitivity, specificity and TOO accuracy of an assay of cfDNA mutation in various types of cancer in different stages		9 months
Secondary	Sensitivity, specificity and TOO accuracy of an assay of cfDNA methylation in various types of cancer in different stages		9 months
Secondary	Sensitivity, specificity and TOO accuracy of an assay of miRNA expression in various types of cancer in different stages		9 months
Secondary	Sensitivity, specificity and TOO accuracy of combined assays of cfDNA mutation, cfDNA methylation and/or miRNA expression in early detection of cancers		9 months