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NCT06633276 | NOT YET RECRUITING | Breast Cancer Invasive

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

University of Bonn

Information provided by (Responsible Party):

Oliver Henke

Brief Summary:

This pilot study will test the feasibility of using nanopore sequencing for breast cancer diagnosis in Tanzania. It aims to show that nanopore sequencing is non-inferior to the current standard of care, with the potential for faster and more cost-efficient results. By enhancing the speed and accuracy of diagnosis, this approach could improve treatment planning and outcomes for patients in resource-limited settings.

Condition or disease

Breast Cancer Invasive

Detailed Description:

Excess fresh tissue samples from patients with suspected breast cancer will undergo nanopore sequencing alongside the current standard of care (SoC), which includes histopathology and biomarker analysis for estrogen receptor, progesterone receptor, and human epidermal growth factor receptor 2 (HER2) status. Low-pass whole genome sequencing and DNA methylation-based classification will potentially enable the diagnosis of invasive ductal breast cancer in a cost-efficient and highly accurate manner. Additionally, breast cancer subtypes can be determined using methylation signatures and HER2 focal amplification, with results available within hours in a point-of-care setting. The primary outcome measures are non-inferiority compared to SoC, turnaround time, and overall feasibility. Treatment is not altered due to results of the nanopore sequencing.

Study Type : OBSERVATIONAL
Estimated Enrollment : 100 participants
Official Title : Nanopore Sequencing for Accelerating Breast Cancer Diagnosis in Tanzania: a Prospective Observational Study
Actual Study Start Date : 2025-04
Estimated Primary Completion Date : 2026-04
Estimated Study Completion Date : 2026-04

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
Inclusion Criteria
  • * Patient with suspected diagnosis of breast cancer undergoing biopsy or surgical resection as per institutional guidelines
  • * Excess fresh tumor sample
  • * Written informed consent
Exclusion Criteria
  • - Unable to provide informed consent
Fast and Accurate Breast Cancer Diagnosis Using Nanopore Sequencing in Tanzania (Fast-ABCD Sequencing)

Location Details

NCT06633276

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Tanzania,

Kilimanjaro Christian Medical Centre

Moshi, Tanzania, P.O. Box 3010