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Colorectal cancer outcomes after screening with the multi-target stool DNA assay: protocol for a large-scale, prospective cohort study (the Voyage study)
  1. Janet E Olson1,2,
  2. Emily J Kirsch1,
  3. David K Edwards V3,
  4. Christine R Kirt4,
  5. Bonny Kneedler5,
  6. Jennifer J Laffin5,
  7. Amy L Weaver6,
  8. Jennifer L St Sauver1,7,
  9. Kathleen J Yost1,7,
  10. Lila J Finney Rutten7,8
  1. 1Division of Epidemiology, Department of Health Sciences Research, Mayo Clinic, Rochester, Minnesota, USA
  2. 2Center for Individualized Medicine, Mayo Clinic, Rochester, Minnesota, USA
  3. 3Exact Sciences Corporation, Madison, Wisconsin, USA
  4. 4Mayo Clinic, Rochester, Minnesota, USA
  5. 5Exact Sciences Laboratories, Madison, Wisconsin, USA
  6. 6Division of Biomedical Statistics and Informatics, Mayo Clinic, Rochester, Minnesota, USA
  7. 7Robert D. and Patricia E. Kern Center for the Science of Healthcare Delivery, Mayo Clinic, Rochester, Minnesota, USA
  8. 8Division of Health Care Policy and Research, Mayo Clinic, Rochester, Minnesota, USA
  1. Correspondence to Dr Janet E Olson; olsonj{at}mayo.edu

Abstract

Introduction Population-level screening has been shown to reduce the incidence and mortality of colorectal cancer (CRC). Unfortunately, adherence to screening recommendations among eligible US adults remains below national goals. A relatively new non-invasive screening modality, the Food and Drug Administration–approved multi-target stool DNA (mt-sDNA) assay (commercialised as Cologuard), which combines the detection of haemoglobin and DNA abnormalities, has been completed by more than 3 million individuals. Given mt-sDNA’s recent availability, the effectiveness of mt-sDNA screening with respect to CRC incidence and mortality reduction has not yet been established.

Methods and analysis Through an academic–industry collaboration, a prospective cohort study (Voyage) was designed with an initial enrolment target of 150 000 individuals with mt-sDNA ordered by their healthcare provider for CRC screening. Consented participants will be asked to complete a baseline questionnaire to collect sociodemographic and health information. Additional questionnaires will be provided after 1 year, and every 3 years thereafter, to collect data regarding CRC screening follow-up in order to estimate rates of CRC incidence and other health outcomes. Linkage to the National Death Index will be used to estimate mortality rates.

Ethics and dissemination The Voyage study will be conducted in accordance with international guidelines and local regulatory requirements and laws. Data will be stored and retained at Mayo Clinic. Only limited data elements required for research purposes will be transmitted between Mayo Clinic and Exact Sciences Laboratories. Results of the Voyage study will be disseminated through scientific presentations and publications.

Trial registration number NCT04124406.

  • cancer prevention
  • colorectal cancer screening
  • colorectal cancer
  • clinical trials
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Footnotes

  • Contributors Conceptualisation: JEO, KJY, LJFR, EJK, JLSS. Methodology: JEO, KJY, LJFR, ALW, JJL. Software: EJK, CRK. Formal analysis: ALW. Investigation: JEO, KJY, LJFR. Resources: JJL, BK. Writing—original draft: DKE, JEO, KJY, LJFR, EJK, CRK, ALW. Writing—review and editing: DKE, JEO, KJY, LJFR, EJK, CRK, ALW, JJL, BK, JLSS. Visualisation: JEO, KJY, EJK. Supervision: EKJ, CRK. Project administration: JEO, EJK, CRK. Funding acquisition: LJFR.

  • Funding This work was supported by Exact Sciences.

  • Competing interests DKE is an employee of Exact Sciences Corporation. BK and JJL are employees of Exact Sciences Laboratories. LJFR offers scientific input to research studies through a contracted services agreement between Mayo Clinic and Exact Sciences. All other authors report no competing interests.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Data availability statement Data are available on reasonable request. Individual participant data that underlie the results reported in publications of the study will be shared after de-identification. This may include text, tables, figures and appendices. The study protocol (including statistical methods), informed consent form and clinical study report will also be shared. Data will be shared with researchers who provide a methodologically sound proposal to achieve the aims outlined in the approved proposal. Data will be available from 2 years and ending 4 years after publication. Proposals for access to data should be directed to clinicaltrials@exactsciences.com. To gain access, data requestors will need to provide a methodologically sound proposal and sign a data access agreement. Researchers are required to obtain necessary IRB/EC approvals or waivers as applicable to conduct research.

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