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P123: Cutaneous T-Cell Lymphoma Identified during Screening for Decentralized Clinical Trial for Atopic Dermatitis - A Case Study

Poster Presenter

Robert Stavert

Medical Director, Dermatology
Science 37
United States

Objectives

To demonstrate how decentralized clinical trials (DCT) may improve access to specialty care for vulnerable patient populations by highlighting a case of a rare and potentially life-threatening condition (cutaneous T-cell lymphoma) identified during remote screening for a DCT.

Method

This is a report of a case of a patient with cutaneous T-cell lymphoma, identified during screening for a fully decentralized clinical trial (DCT) for atopic dermatitis. The clinical research team coordinated with an academic medical center to confirm the suspected diagnosis and initiate treatment.

Results

Cutaneous T-cell lymphoma (CTCL) is a rare and potentially fatal cancer of the skin. The diagnosis of CTCL is often delayed because early on CTCL may mimic common inflammatory skin diseases, including atopic dermatitis. African-American patients with CTCL tend to be diagnosed at a more advanced stage and have poorer outcomes compared to white patients. This report describes the case of an African-American woman who was screened via telemedicine and remote photography for participation in a decentralized clinical trial for atopic dermatitis. During the screening process, concern for a possible diagnosis of CTCL was raised by a dermatologist member of the research team. The patient was deemed ineligible for the study. The research team coordinated with an academic medical center to ensure the patient received appropriate evaluation and follow-up. The suspected diagnosis of CTCL was confirmed at the academic medical center, where the patient has been receiving appropriate therapy.

Conclusion

This case study is noteworthy in several aspects. First, the case highlights a rare and potentially fatal dermatologic condition which may often be misdiagnosed. Additionally, the case highlights how the DCT model may facilitate access to care for vulnerable patient populations. Many patients encounter barriers in accessing specialty medical care, including geographic limitations, lack of insurance coverage, and costly out of pocket expenses. In some cases, challenges in accessing care may contribute to individuals’ interest in participating in clinical trials. This may be especially true for patients participating in decentralized clinical trials, which can reduce the burden on patients by facilitating participation in the trial from the patient’s home. In this case, the patient’s condition was identified during remote screening for potential participation in a decentralized clinical trial. This highlights how the DCT model can provide patients with a unique opportunity to access clinical expertise. The case also demonstrates the importance of leveraging true clinical domain expertise in order to ensure patient safety and data integrity in clinical trials. This patient’s diagnosis was suspected via a combination of telemedicine and remote photography, highlighting the capabilities of these modalities to accurately assess and diagnose patients. This case also highlights the importance of care coordination to ensure that patients in clinical trials receive appropriate medical care.