SYMPLIFY – assessing a multi-cancer early detection test in individuals referred with signs and symptoms of cancer

Conditions

Early detection of cancer Cancer

Ashley Jackson, Pradeep S. Virdee, Sharon Tonner, Jason L. Oke, Rafael Perera et al. (11 authors)

The Lancet Regional Health - Europe2026-05-28

10.1016/j.lanepe.2026.101720

Clinical Utility of Multicancer Detection in Symptomatic Patients: A Decision-Making Perspective.

Netto Flores Cruz G, Korthauer K.

2025-12-05

10.1200/po-25-00279

Validity and timeliness of cancer diagnosis data collected during a prospective cohort study and reported by the English and Welsh cancer registries: a retrospective, comparative analysis.

Jackson A, Virdee PS, Tonner S, Oke JL, Perera R, Riahi K, Luan Y, Hiom S, Kumar H, Nandani H, Kurtzman KN, Huws D, Allan D, Smits S, McPhail S, Parkes EE, Hobbs FDR, Middleton MR, Nicholson BD.

2024-10-095 citations

10.1016/s1470-2045(24)00497-2

Multi-cancer early detection test in symptomatic patients referred for cancer investigation in England and Wales (SYMPLIFY): a large-scale, observational cohort study.

Nicholson BD, Oke J, Virdee PS, Harris DA, O'Doherty C, Park JE, Hamady Z, Sehgal V, Millar A, Medley L, Tonner S, Vargova M, Engonidou L, Riahi K, Luan Y, Hiom S, Kumar H, Nandani H, Kurtzman KN, Yu LM, Freestone C, Pearson S, Hobbs FR, Perera R, Middleton MR.

2023-06-20111 citations

10.1016/s1470-2045(23)00277-2

Large-scale observational prospective cohort study of a multi-cancer early detection (MCED) test in symptomatic patients referred for cancer investigation.

Brian D Nicholson, Oke Jason, Dean Harris, Catherine O’Doherty, John ES Park et al. (20 authors)

Journal of Clinical Oncology2023-06-011 citations

10.1200/jco.2023.41.16_suppl.1501

Interventions

Participants will be asked to give consent and provide a single blood sample during one visit to hospital. After that the participants have no further direct involvement, all follow-up is through col

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Inclusion criteria

Inclusion criteria: 1. Participants referred to an RDC or relevant 2WW pathway to rule a cancer diagnosis in or out will be invited to participate in the study. 2. Willing and able to give informed consent for participation in the study. 3. Male or Female, aged 18 years or above. 4. Referred to a RDC or a gynae, lung, upper GI or lower GI cancer 2WW pathway.

Exclusion criteria

Exclusion criteria: 1. Has a history of invasive or haematological malignancy diagnosed within the previous 3 years. 2. Has undergone definitive treatment for invasive or haematological malignancy in the last 3 years (adjuvant hormone therapy is permissible in this context). 3. Is taking cytotoxic or demethylating agents such as methotrexate. 4. Previous or current participation in another GRAIL study. “Participation” is defined as having signed consent and provided a blood sample.

Design outcomes

Primary

Measure	Time frame
At an interim analysis within 3 months of complete enrolment with complete analysis at 12 months of enrolment, measured by comparing blood sample analysis and patient notes: 1. Positive Predictive Value 2. Negative Predictive Value 3. Sensitivity 4. Specificity 5. Cancer signal origin accuracy	—

Secondary

Measure	Time frame
At an interim analysis within 3 months of complete enrolment with complete analysis at 12 months of enrolment, measured by comparing blood sample analysis and patient notes: 1. Concordance between referral pathway selected by GP and CSOs identified by MCED 2. Number of true positives/number of patients referred within each referral pathway	—

Countries

England, United Kingdom, Wales

Contacts

Public ContactSarah Pearson

octo-symplify@oncology.ox.ac.uk+44 (0)1865 227170

Outcome results

None listed