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Grocery Chain Offering Sites for Cancer Biomarker Trial

Kroger store in Kentucky

Kroger store in Shepherdsville, Kentucky (Ambrosia LaFluer, Flickr.

25 Jan. 2023. The Kroger grocery store chain in the U.S. is establishing a clinical trial network through its urgent care centers, starting with a study of microbiome cancer biomarkers. The trial is an observational study of microbial communities in the gut to identify precise biomarkers of immune health affecting four types of solid-tumor cancers.

The Kroger Company, based in Cincinnati, Ohio,  is a chain of some 2,800 stores in 35 states, with sales of more than $32.5 billion, according to the company. The chain provides urgent care services at 226 of its stores called Little Clinics offering walk-in, appointment, and telehealth services for diagnostics, screenings, physicals, minor injuries, and vaccinations. The clinics, says the company, are staffed with nurse practitioners and physician assistants, and open seven days a week, including evenings. Kroger also operates more than 2,200 in-store pharmacies.

Kroger says its Little Clinics and pharmacies are now available to serve as clinical trial sites. The chain’s first trial seeks to identify biomarkers, or molecular identifiers, of four solid-tumor cancers: non-small cell lung cancer, triple negative breast cancer, colorectal cancer, and pancreatic cancer. The clinical trial, conducted by Persephone Biosciences Inc. in San Diego, is an observational study that aims to enroll up to 4,000 patients with these four types of cancer in stage 3, where the cancer grows and spreads to lymph nodes or other tissues, or stage 4, where the cancer spreads to other organs, known as metastatic cancer.

Enrolling those at risk for colorectal cancer

The trial’s study team is collecting at least two blood and stool samples from the cancer patients, then tracked for up to eight years. Persephone Bio, a developer of engineered biologics addressing microbiome disorders, is collecting the samples in a biobank for detailed analysis, tied to the patients’ electronic health records. The company’s analysis aims to connect the condition of patients’ microbiome, communities of bacteria in the gut, with genomic and metabolic conditions. Science & Enterprise reported in Sept 2022 on the start of the trial.

Kroger’s Little Clinics and pharmacies are participating in the colorectal cancer part of Persephone Bio’s study. The chain is seeking participants age 45 or over normally candidates for a colonoscopy, those age 18 or over with first-degree relatives with a colon cancer history, and individuals with a personal history of colorectal cancer or found with three or more polyps in a colonoscopy. Kroger says its clinics and pharmacies in the Toledo, Ohio region are the first sites taking part in the trial, with a goal of enrolling 55 participants.

One of Persephone Bio’s objectives in the trial is to enroll a more racially diverse patient population than usually recruited in clinical studies. Kroger says about half (51%) of its stores are located in “socially vulnerable areas”. The company says with these locations, it can enroll more diverse clinical trial samples, and use personalized digital tools, such as virtual visits, to increase retention rates.

“This is the first of many clinical trial opportunities,” says James Kirby, chief commercial officer of Kroger Health in a company statement, “that will utilize us as an alternative to the traditional clinical trial and research organization model.” Kroger stores are not alone in offering their widespread retail locations as clinical trial sites. Walmart, Walgreens, and CVS also offer their stores and clinics for recruiting more diverse clinical trial participants.

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