Implementing non-invasive biospecimen collection in gynecologic oncology: Insights from a prospective gut microbiome...

The gut microbiome is increasingly recognized as an important modulator of treatment response and other outcomes in gynecologic cancers, but data are limited regarding the logistics of incorporating stool sample collection into clinical practice. We evaluated the feasibility of integrating non-invasive stool biospecimen collection into routine gynecologic oncology care, described recruitment and compliance, and identified factors associated with participation.

This prospective, single-institution study was conducted from March 2023 to April 2024. Eligible gynecologic oncology patients were approached for Total Cancer Care® enrollment and offered participation in an optional linked stool biospecimen substudy. Patients who consented received an at-home stool collection kit. Clinical and demographic data were abstracted from the electronic medical record, and multivariable logistic regression identified predictors of Total Cancer Care enrollment, stool kit acceptance, and stool kit return.

A total of 666 patients were approached, of whom 407 (61%) enrolled in Total Cancer Care. Among enrollees, 234 (58%) accepted a stool kit, and 100 (43%) of those who accepted returned a completed sample. On multivariable analysis, prior clinical trial participation (p < 0.01) and provider (p < 0.05) were independently associated with Total Cancer Care enrollment. Stool kit acceptance was most strongly predicted by treating provider (p < 0.0001). No demographic or clinical variables were significantly associated with kit return.

Implementation of an at-home stool collection program in gynecologic oncology is feasible. Provider engagement was the strongest determinant of acceptance. These findings provide real-world benchmarks for recruitment and compliance and establish a foundation for future microbiome-focused translational studies.