Smith, Rebecca A. https://orcid.org/0009-0008-3667-4740
Cao, Xiting
Cuyun Carter, Gebra https://orcid.org/0000-0002-6549-0069
Fayyaz, Ifrah https://orcid.org/0000-0002-4072-6629
Pope, Andreyah
Ellenberg, Phil
Miller-Wilson, Lesley-Ann
Limburg, Paul J. https://orcid.org/0000-0002-2428-5675
Pyenson, Bruce https://orcid.org/0000-0003-0416-9391
Article History
Received: 21 May 2025
Accepted: 17 November 2025
First Online: 25 November 2025
Declarations
:
: The WIRB-Copernicus Group (WCG) IRB reviewed our study (Sponsor Protocol No.: 4500062855) under the Common Rule and applicable guidance and declared it exempt from IRB review under 45 CFR § 46.104(d)(4). WCG IRB is registered with FDA/OHRP. WCG IRB registration number is IRB00000533, and WCG IRB’s parent organization number is IORG0000432. WCG IRB reviewed our research in accordance with The Health and Human Services (HHS) Regulations on research with human beings (45 CFR 46 Subparts A, B, C, and D), as it used SEER registry data obtained from the National Cancer Institute. The HHS regulations apply to research that is funded by or use assets from HHS or other institutions that have adopted “the Common Rule,” represented at 45 CFR 46, Subpart A. The exemption letter can be provided to the Editor upon request. Our study adhered to the Declaration of Helsinki.
: Consent to participate was deemed unnecessary by the WCG IRB under the Common Rule and applicable guidance under 45 CFR § 46.104(d)(4). WCG IRB is registered with FDA/OHRP. WCG IRB registration number is IRB00000533, and WCG IRB’s parent organization number is IORG0000432. WCG IRB reviewed our research in accordance with The Health and Human Services (HHS) Regulations on research with human beings (45 CFR 46 Subparts A, B, C, and D), as it used SEER registry data obtained from the National Cancer Institute. The HHS regulations apply to research that is funded by or use assets from HHS or other institutions that have adopted “the Common Rule,” represented at 45 CFR 46, Subpart A.
: Not applicable.
: This work was funded by Exact Sciences Corporation, and some of the authors are employed by (or were previously employed by) Exact Sciences.