Evaluation of Cell-free DNA Long Fragments in the Triage of FIT+ Patients Enrolled in a Colorectal Cancer Screening Program: An Italian Prospective, Cross-Sectional Study

Mauro Scimia; Francesco Pepe; Gianluca Russo; Umberto Malapelle; Simone Scimia; Annalaura Alfieri; Valentina Olivieri; Rachel Chuang; Hiromi Tanaka; Michael Sha; David Chen; Shuo Shen; Claudia Scimone; Lucia Palumbo; Yulia Gavrilov; Stav Edelstein; Maria Antonia Bianco; Giancarlo Troncone

doi:10.20944/preprints202410.0259.v1

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preprints.org > medicine and pharmacology > oncology and oncogenics > doi: 10.20944/preprints202410.0259.v1 (registering DOI)

Preprint Article Version 1 This version is not peer-reviewed

Evaluation of Cell-free DNA Long Fragments in the Triage of FIT+ Patients Enrolled in a Colorectal Cancer Screening Program: An Italian Prospective, Cross-Sectional Study

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Version 1 : Received: 2 October 2024 / Approved: 3 October 2024 / Online: 3 October 2024 (12:30:08 CEST)

How to cite: Scimia, M.; Pepe, F.; Russo, G.; Malapelle, U.; Scimia, S.; Alfieri, A.; Olivieri, V.; Chuang, R.; Tanaka, H.; Sha, M.; Chen, D.; Shen, S.; Scimone, C.; Palumbo, L.; Gavrilov, Y.; Edelstein, S.; Bianco, M. A.; Troncone, G. Evaluation of Cell-free DNA Long Fragments in the Triage of FIT+ Patients Enrolled in a Colorectal Cancer Screening Program: An Italian Prospective, Cross-Sectional Study. Preprints 2024, 2024100259. https://doi.org/10.20944/preprints202410.0259.v1 Scimia, M.; Pepe, F.; Russo, G.; Malapelle, U.; Scimia, S.; Alfieri, A.; Olivieri, V.; Chuang, R.; Tanaka, H.; Sha, M.; Chen, D.; Shen, S.; Scimone, C.; Palumbo, L.; Gavrilov, Y.; Edelstein, S.; Bianco, M. A.; Troncone, G. Evaluation of Cell-free DNA Long Fragments in the Triage of FIT+ Patients Enrolled in a Colorectal Cancer Screening Program: An Italian Prospective, Cross-Sectional Study. Preprints 2024, 2024100259. https://doi.org/10.20944/preprints202410.0259.v1

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MDPI and ACS Style

Scimia, M.; Pepe, F.; Russo, G.; Malapelle, U.; Scimia, S.; Alfieri, A.; Olivieri, V.; Chuang, R.; Tanaka, H.; Sha, M.; Chen, D.; Shen, S.; Scimone, C.; Palumbo, L.; Gavrilov, Y.; Edelstein, S.; Bianco, M. A.; Troncone, G. Evaluation of Cell-free DNA Long Fragments in the Triage of FIT+ Patients Enrolled in a Colorectal Cancer Screening Program: An Italian Prospective, Cross-Sectional Study. Preprints 2024, 2024100259. https://doi.org/10.20944/preprints202410.0259.v1

APA Style

Scimia, M., Pepe, F., Russo, G., Malapelle, U., Scimia, S., Alfieri, A., Olivieri, V., Chuang, R., Tanaka, H., Sha, M., Chen, D., Shen, S., Scimone, C., Palumbo, L., Gavrilov, Y., Edelstein, S., Bianco, M. A., & Troncone, G. (2024). Evaluation of Cell-free DNA Long Fragments in the Triage of FIT+ Patients Enrolled in a Colorectal Cancer Screening Program: An Italian Prospective, Cross-Sectional Study. Preprints. https://doi.org/10.20944/preprints202410.0259.v1

Chicago/Turabian Style

Scimia, M., Maria Antonia Bianco and Giancarlo Troncone. 2024 "Evaluation of Cell-free DNA Long Fragments in the Triage of FIT+ Patients Enrolled in a Colorectal Cancer Screening Program: An Italian Prospective, Cross-Sectional Study" Preprints. https://doi.org/10.20944/preprints202410.0259.v1

Abstract

Background: Colorectal Cancer screening programs are effective in reducing incidence and mor-tality. In Europe, every FIT+ patient is referred to colonoscopy. Available data shows that ~75.0% of these patients are negative. It is desirable to select patients at greater risk of having a positive colonoscopy. Methods: 711 subjects, aged 50-74, attending the screening program of ASL-NA-3-SUD (Na-ples, Italy), were enrolled in a cross-sectional study to evaluate the performance of QuantiDNA™ test and non-inferiority of an alternative approach (AAP). This evaluation is based on FIT+ and QuantiDNA™+ patients referred to colonoscopy, compared to Standard of Care (SOC), colon-oscopy following a FIT+ test alone. A non-inferiority margin for Colorectal Neoplasia (CN) and Advanced Adenomas (AA) was set at -10% and at -3.8% for CRC. Results: The odds ratio was 1.76 (p-value= 0.009). The detection rate of AAP was 15.9% for colorectal neoplasia (CN), 13.0% for advanced adenoma (AA), and 3.0% for CRC. The risk dif-ference between AAP and SOC was -5.07% (95% C.I -9.23, -0.90) for CN, -4.02% (95% C.I. -7.89, -0.16) for AA, and -1.04% (95% C.I. -3.16, 1.07) for CRC. This data suggests that AAP is non-inferior to SOC for detecting CN, AA, and CRC. The expected decrease in colonoscopies is 33.4%. Conclusions: The QuantiDNA™ test is straightforward, non-invasive, and well-tolerated. Data from this study indicates it is effective in the reduction of the need for colonoscopy examina-tions (-33.4%) and is non-inferior to SOC in the detection of significant colorectal lesions.

Keywords

colorectal cancer screning; colorectal cancer; genetic testing

Subject

Medicine and Pharmacology, Oncology and Oncogenics

Copyright: This is an open access article distributed under the Creative Commons Attribution License which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

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