RT Journal Article
SR Electronic
T1 Colorectal cancer outcomes after screening with the multi-target stool DNA assay: protocol for a large-scale, prospective cohort study (the Voyage study)
JF BMJ Open Gastroenterology
JO BMJ Open Gastro
FD BMJ Publishing Group Ltd
SP e000353
DO 10.1136/bmjgast-2019-000353
VO 7
IS 1
A1 Janet E Olson
A1 Emily J Kirsch
A1 David K Edwards V
A1 Christine R Kirt
A1 Bonny Kneedler
A1 Jennifer J Laffin
A1 Amy L Weaver
A1 Jennifer L St Sauver
A1 Kathleen J Yost
A1 Lila J Finney Rutten
YR 2020
UL http://bmjopengastro.bmj.com//content/7/1/e000353.abstract
AB 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.