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

NCT ID: NCT06633276

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-31
• Study Completion Date: 2026-05-31

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.

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.

Conditions

Breast Cancer Invasive

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Nanopore sequencing

All adult patients at with suspected diagnosis of breast cancer undergoing biopsy or surgical resection will be offered to participate in the study. After informed written consent excess tissue is preserved for DNA extraction using commercial spin column kits and will be further analyzed.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Patient with suspected diagnosis of breast cancer undergoing biopsy or surgical resection after specialist consultation as per institutional guidelines
• Excess fresh tumor sample
• Written informed consent

Exclusion Criteria

• Unable to provide informed consent
• Patients who have already commenced therapy for BC (except for treatment other than biomedicine, e.g. herbal medicines)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Cancer Research Center

OTHER

Sponsor Role: collaborator

Kilimanjaro Christian Medical Centre,Moshi,Tanzania

UNKNOWN

Sponsor Role: collaborator

University of Bonn

OTHER

Sponsor Role: lead

Responsible Party

Oliver Henke

Head of Working Group Global Oncology, Section Global Health, University Hospital Bonn

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oliver Henke, MD

Role: PRINCIPAL_INVESTIGATOR

Section Global Health, University Hospital Bonn

Locations

Kilimanjaro Christian Medical Centre

Moshi, , Tanzania

Site Status: RECRUITING

Countries

Tanzania

Central Contacts

Oliver Henke, MD

Role: CONTACT

Oliver.Henke@ukbonn.de

+49 (0) 228 287 51521

Maximilian Rost, MD

Role: CONTACT

maximilian.rost@ukbonn.de

+49 (0) 228 287 51521

Facility Contacts

Oliver Henke

Role: primary

Oliver.Henke@ukbonn.de

+255 (0) 76 1511227

Other Identifiers

23Ac03011

Identifier Type: -

Identifier Source: org_study_id