Blood Cell RNA-Based Cancer Detection (eRBCDet)

A Blinded Prospective Study on Development and Validation of the Blood Cell RNA-Based Cancer Detection

Early diagnosis of cancer may provide patients with more treatment options and hopefully prolong survival. The purpose of this multi-center study is to collect peripheral blood from newly diagnosed cancer patients and healthy donors to establish a blood cell RNA-based model for the differentiation of cancer patients and healthy donors. The area under the receiver operating characteristic (AUROC), sensitivity and specificity of the test in the early detection of multiple cancers will be measured.

Study Overview

• Status: Recruiting
• Conditions: Neoplasms; Cancer
• Intervention / Treatment: Diagnostic test: Blood test

• Study Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

• Study Contact: Name: Zheng Wang, MD/PhD; Phone Number: +86 27 85726612; Email: zhengwang@hust.edu.cn
• Study Contact Backup: Name: Luming Xu; Phone Number: +86 27 85726612; Email: lumingxu@hust.edu.cn

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430022
      • Recruiting
      • Zheng Wang
      • Contact: Zheng Wang, MD/PhD; Phone Number: +86 27 85726612; Email: zhengwang@hust.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Newly diagnosed cancer patients and healthy donors will be recruited from medical centers.

Description

Inclusion Criteria for All the Participants

1. Age 18 years or older
2. Provide informed consent

Exclusion Criteria for All the Participants:

1. Pregnancy or lactating women
2. Received a blood transfusion within 1 month
3. Received anti-cancer treatment within 3 years
4. Known prior diagnosis of cancer
5. Poor health status or unfit to tolerate blood draw

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cancer; Patients with new diagnosis of cancers	Diagnostic test: Blood test; RNA sequencing of peripheral blood cells
Non-cancer; Healthy participants	Diagnostic test: Blood test; RNA sequencing of peripheral blood cells

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sensitivity and specificity of cancer detection	Sensitivity and specificity of the early detection of 30 types of cancers of a blood cell RNA-based cancer detection test	1 year
Accuracy of TOO prediction	Accuracy of the tissue of origin (TOO) prediction of a blood cell RNA-based cancer detection test	1 year

Collaborators and Investigators

• Sponsor: Wuhan Union Hospital, China
• Investigators: Study Chair: Zheng Wang, MD/PhD, Wuhan Union Hospital, China

Publications and helpful links

General Publications

• Liu MC, Oxnard GR, Klein EA, Swanton C, Seiden MV; CCGA Consortium. Sensitive and specific multi-cancer detection and localization using methylation signatures in cell-free DNA. Ann Oncol. 2020 Jun;31(6):745-759. doi: 10.1016/j.annonc.2020.02.011. Epub 2020 Mar 30.
• Mellby LD, Nyberg AP, Johansen JS, Wingren C, Nordestgaard BG, Bojesen SE, Mitchell BL, Sheppard BC, Sears RC, Borrebaeck CAK. Serum Biomarker Signature-Based Liquid Biopsy for Diagnosis of Early-Stage Pancreatic Cancer. J Clin Oncol. 2018 Oct 1;36(28):2887-2894. doi: 10.1200/JCO.2017.77.6658. Epub 2018 Aug 14.
• Best MG, Sol N, Kooi I, Tannous J, Westerman BA, Rustenburg F, Schellen P, Verschueren H, Post E, Koster J, Ylstra B, Ameziane N, Dorsman J, Smit EF, Verheul HM, Noske DP, Reijneveld JC, Nilsson RJA, Tannous BA, Wesseling P, Wurdinger T. RNA-Seq of Tumor-Educated Platelets Enables Blood-Based Pan-Cancer, Multiclass, and Molecular Pathway Cancer Diagnostics. Cancer Cell. 2015 Nov 9;28(5):666-676. doi: 10.1016/j.ccell.2015.09.018. Epub 2015 Oct 29.
• Klein EA, Richards D, Cohn A, Tummala M, Lapham R, Cosgrove D, Chung G, Clement J, Gao J, Hunkapiller N, Jamshidi A, Kurtzman KN, Seiden MV, Swanton C, Liu MC. Clinical validation of a targeted methylation-based multi-cancer early detection test using an independent validation set. Ann Oncol. 2021 Sep;32(9):1167-1177. doi: 10.1016/j.annonc.2021.05.806. Epub 2021 Jun 24.
• Best MG, Sol N, In 't Veld SGJG, Vancura A, Muller M, Niemeijer AN, Fejes AV, Tjon Kon Fat LA, Huis In 't Veld AE, Leurs C, Le Large TY, Meijer LL, Kooi IE, Rustenburg F, Schellen P, Verschueren H, Post E, Wedekind LE, Bracht J, Esenkbrink M, Wils L, Favaro F, Schoonhoven JD, Tannous J, Meijers-Heijboer H, Kazemier G, Giovannetti E, Reijneveld JC, Idema S, Killestein J, Heger M, de Jager SC, Urbanus RT, Hoefer IE, Pasterkamp G, Mannhalter C, Gomez-Arroyo J, Bogaard HJ, Noske DP, Vandertop WP, van den Broek D, Ylstra B, Nilsson RJA, Wesseling P, Karachaliou N, Rosell R, Lee-Lewandrowski E, Lewandrowski KB, Tannous BA, de Langen AJ, Smit EF, van den Heuvel MM, Wurdinger T. Swarm Intelligence-Enhanced Detection of Non-Small-Cell Lung Cancer Using Tumor-Educated Platelets. Cancer Cell. 2017 Aug 14;32(2):238-252.e9. doi: 10.1016/j.ccell.2017.07.004.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2021
• Primary Completion (Anticipated): June 1, 2023
• Study Completion (Anticipated): October 8, 2024

Study Registration Dates

• First Submitted: July 12, 2022
• First Submitted That Met QC Criteria: April 20, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: blood-cell-RNA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No