Blood Cell RNA-Based Cancer Detection

NCT05839834 | Recruiting DMC

• 1 other identifier: blood-cell-RNA
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Neoplasms; Cancer

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Cancer

Patients with new diagnosis of cancers

Diagnostic Test: Blood test

Non-cancer

Healthy participants

Diagnostic Test: Blood test

Interventions

Blood test DIAGNOSTIC_TEST

RNA sequencing of peripheral blood cells

Cancer; Non-cancer

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age 18 years or older
• Provide informed consent

You may not qualify if:

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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Zheng Wang

Wuhan, Hubei, 430022, China

RECRUITING

Related Publications (5)

• 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.

  PMID: 30106639 BACKGROUND

• 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.

  PMID: 33506766 BACKGROUND

• 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.

  PMID: 34176681 BACKGROUND

• 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.

  PMID: 28810146 BACKGROUND

• 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.

  PMID: 26525104 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood

MeSH Terms

Conditions

Neoplasms

Interventions

Hematologic Tests

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Study Officials

• Zheng Wang, MD/PhD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY CHAIR

Central Study Contacts

Zheng Wang, MD/PhD

CONTACT

+86 27 85726612; zhengwang@hust.edu.cn

Luming Xu

CONTACT

+86 27 85726612; lumingxu@hust.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Study chair, Clinical Professor

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: May 3, 2023
• Study Start: February 8, 2021
• Primary Completion: November 1, 2024
• Study Completion: December 8, 2024
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)