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

NCT04972201 | Completed DMC

• 1 other identifier: RSCD2020006
• Study Type: observational
• Target: 2,305
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cancer

Keywords

cancer; liquid biopsy; cell-free DNA (cfDNA); microRNA (miRNA); early detection

Outcome Measures

Primary Outcomes (1)

• 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

  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 Outcomes (4)

• Sensitivity, specificity and TOO accuracy of an assay of cfDNA mutation in various types of cancer in different stages

  9 months

• Sensitivity, specificity and TOO accuracy of an assay of cfDNA methylation in various types of cancer in different stages

  9 months

• Sensitivity, specificity and TOO accuracy of an assay of miRNA expression in various types of cancer in different stages

  9 months

• Sensitivity, specificity and TOO accuracy of combined assays of cfDNA mutation, cfDNA methylation and/or miRNA expression in early detection of cancers

  9 months

Study Arms (2)

Cancer Arm

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

Device: Multi-cancer early detection test

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 test

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 two arms, including participants with new diagnosis of cancers and healthy participants.

You may qualify if:

• Ability to provide a written informed consent
• 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

You may not qualify if:

• 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
• Ability to provide a written informed consent
• 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
• 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

Sponsors & Collaborators

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

Study Sites (1)

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Beijing, China

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Jie Wang, M.D., Ph.D.

  Cancer Institute and Hospital, Chinese Academy of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 22, 2021
• Study Start: June 1, 2021
• Primary Completion: March 31, 2022
• Study Completion: June 30, 2022
• Last Updated: December 27, 2024

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)