189P - Design and enrollment for a classifier development study for a blood-based multi-cancer early detection (MCED) test

Background

The aim of the Ascertaining Serial Cancer patients to Enable New Diagnostic 2 (ASCEND 2) case-control study is to develop a classifier algorithm for a refined version of a multi-analyte blood-based MCED test. Here, we report the study design, enrollment, and sample selection from this large, multi-center, prospective, case-control study of clinically characterized participants.

Methods

The ASCEND 2 study engaged 151 sites within the US and Europe for subject enrollment. Samples consisted of blood collected using LBgard® tubes for plasma and buffy samples. The study population includes male and female subjects ≥50 years old with known cancer, suspicion of cancer, and controls without cancer. All subjects provided informed consent and were assessed for study participation eligibility.

Results

Over 11,000 subjects were enrolled in this study. A subset of 6361 samples was selected to develop and refine a multi-analyte cancer detection classifier. The subset includes 1440 cancer subjects, from more than 18 organ sites reflective of US cancer incidence by tumor type, and 4921 age-matched subjects without suspicion of cancer. Demographics are reported in in the table. Cancer cases include stage I (388), stage II (301), stage III (374), stage IV (317), stage unknown (60). The samples will be partitioned into training and independent test sets. The performance of one or more locked cancer detection models developed in the training phase will be tested.

Table: 189P

Demographics

Conclusions

The ASCEND 2 study selected cancer types in an incidence-targeted manner, including rare and common cancers and evenly distributed stages. By enrolling a racially, ethnically, and geographically diverse cohort, the current study enables MCED test development with a representative cohort.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Exact Sciences Corporation.

Funding

Exact Sciences Corporation.

Disclosure

C. Douville: Financial Interests, Personal, Advisory Role: Exact Sciences Corporation; Financial Interests, Personal, Royalties: Johns Hopkins University. L. Hogstrom, V. Gainullin, H.J. Hwang, S. Chowbina, Y. Zhang, M. Gray, M. Kumar, M. Manesse, F. Zhuang, V. Fa, X. Chen, A. Mcelhinny, G. Cerqueira, S. Rego, F. Diehl : Financial Interests, Personal, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Personal, Stocks/Shares: Exact Sciences Corporation. J. Garces: Financial Interests, Personal, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Personal, Stocks/Shares: Exact Sciences Corporation; Financial Interests, Personal, Officer, CSO: Exact Sciences Corporation. G.A. Silvestri: Financial Interests, Personal, Other, Honoraria: AstraZeneca; Financial Interests, Personal, Advisory Role: Olympus Medical Systems, Biodesix, AstraZeneca, Daiichi Sankyo; Financial Interests, Institutional, Research Funding: Olympus, Biodesix, Seer, Amgen. T.M. Beer: Financial Interests, Personal, Full or part-time Employment: Exact Sciences Corporation; Financial Interests, Personal, Stocks/Shares: Exact Sciences Corporation, Arvinas, Salarius Pharmaceuticals; Financial Interests, Personal, Advisory Role: AbbVie, Amgen, Arvinas, Astellas Pharma, AstraZeneca, Bayer, Bristol Myers Squibb, Constellation Pharmaceuticals, Dantari Pharmaceuticals, GSK, GRAIL, Janssen, Pfizer, Sanofi, Sapience Therapeutics; Financial Interests, Institutional, Research Funding: Alliance Foundation Trials, Astellas Pharma, Bayer, Boehringer Ingelheim, Corcept Therapeutics, Endocyte, Freenome, GRAIL, Harpoon Therapeutics, Janssen R&D, Medivation, Sotio, Theraclone Sciences, Zenith Epigenetics.