A New Pathway for a Rare Disease

For people living with extramammary Paget’s disease (EMPD), one of the greatest challenges has always been the lack of research. EMPD is so rare that traditional clinical trials are difficult to run, and many patients have never had the opportunity to participate in a study focused on their own cancer.

The Transformative Rare Cancer (TRACER) Initiative at the Fred Hutchinson Cancer Research Center in Seattle aims to change that. TRACER was created specifically for rare and ultra-rare cancers, where the usual research approach breaks down because there are simply too few patients. Instead of waiting for large patient groups, TRACER learns from each individual case. A small amount of fresh tumor tissue, collected during a biopsy or surgery, becomes the starting point for a detailed, personalized analysis of how that tumor responds to treatment.

How TRACER Works

When an EMPD patient is scheduled for a biopsy or surgery, a portion of the fresh tissue can be sent to TRACER. The program provides everything required: a collection kit, instructions for the clinical team, consent materials, and prepaid overnight shipping. There is no cost to the patient or the physician.

After the sample arrives, the TRACER team preserves it as intact pieces of tumor. This approach matters because whole tissue behaves more like a real tumor in the body than single cells grown in a dish. It provides a more accurate picture of how a cancer may respond to therapy.

The scientists begin by testing a small set of FDA-approved drugs directly on the intact tissue. These early results are then used to train a machine-learning model that predicts how the tumor might respond to nearly all FDA-approved medications, roughly 1,800 in total. The most promising predicted drugs can then be tested on the preserved tumor sample. Even with a very small amount of tissue, this combined laboratory and computational method can produce meaningful results in a short amount of time. Initial findings are usually ready in about seven days.

Why This Matters for EMPD

For people with EMPD, especially those with invasive or metastatic disease, treatment decisions are often made with very little data. TRACER offers a research pathway that has never existed before. A single tumor sample can provide individualized information about potential drug sensitivities, giving patients and their physicians new data to consider at moments when choices may feel limited.

As more EMPD samples are studied, researchers can begin to compare cases, identify shared patterns, and build the foundation for future therapies or clinical trials. These steps have historically been out of reach for EMPD because of how rarely the disease appears.

Just as important, TRACER focuses on real tumor behavior rather than genetics alone. Because the testing uses intact tissue, the results may better reflect the complexity of EMPD, including cases that have spread beyond the skin.

The program is supported by a five-year grant from the U.S. Food and Drug Administration (FDA), which encourages innovative approaches to rare cancer research. Regular review with the FDA ensures scientific oversight and continued program growth. TRACER now includes more than twenty rare and ultra-rare cancers, with EMPD among the latest to be studied.

For a community that has waited many years for focused attention TRACER offers more than a scientific platform—it offers momentum. It offers a way forward.

How to Participate

TRACER is intended for patients with invasive or metastatic EMPD. Patients scheduled for a biopsy or surgery that can provide fresh tumor tissue may be eligible. The program supplies a complete collection kit, instructions for the clinical team, consent materials, and prepaid overnight shipping at no cost.

Physicians place the fresh tumor tissue, along with matched normal tissue and a blood sample when available, into the provided containers and ship the kit overnight to Fred Hutch. TRACER manages the remaining steps, including laboratory testing and computational analysis. To learn more or to request a kit, contact the TRACER team.