Nanopore Sequencing to Speed Up Breast Cancer Diagnosis in Tanzania A Study Comparing New Genetic Testing with Standard Methods

What this Trial Is About

Researchers are evaluating the use of nanopore sequencing to diagnose breast cancer in Tanzania. This observational study aims to show that this new sequencing method is not worse than the current standard of care, which includes histopathology and biomarker analysis for estrogen receptor, progesterone receptor, and HER2 status. The goal is to provide faster, cost-efficient, and accurate diagnosis to improve treatment planning in resource-limited settings. In this study, excess fresh tissue from patients suspected of having breast cancer will be analyzed using nanopore sequencing alongside the standard methods. This sequencing includes low-pass whole genome analysis and DNA methylation-based classification to identify breast cancer and its subtypes quickly, potentially delivering results within hours at the point of care. The study does not alter treatment based on nanopore sequencing results. Participants will provide excess tissue samples collected during biopsy or surgical resection after consent. Researchers will continuously assess the agreement between nanopore sequencing and standard care, the feasibility of the method, and the time taken to deliver results over about one year. Quality of life and patient experiences with diagnostic procedures will also be evaluated using questionnaires at baseline, 6 months, and 12 months after enrollment.

Fast and Accurate Breast Cancer Diagnosis Using Nanopore Sequencing in Tanzania (Fast-ABCD Sequencing)