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

NCT06633276 | Recruiting

• 1 other identifier: 23Ac03011
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Invasive

Keywords

Nanopore sequencing; breast cancer

Outcome Measures

Primary Outcomes (3)

• Non-inferiority of nanopore-based biomarker evaluation

  Concordance of invasive breast cancer diagnosis using nanopore sequencing vs. IHC HR/HER2 status as standard of care. The concordance will be expressed as the percentage agreement between the two methods across 100 patients.

  Concordance will be assessed after the enrollment of each cohort of 25 patients, with the final evaluation after study completion, approximately 12 months from enrollment start.

• Feasibility

  Feasibility will be measured by calculating the ratio of samples that are successfully sequenced and analyzed using nanopore sequencing technology, compared to the total number of samples processed.

  The ratio will be assessed continuously after the sequencing of each batch of samples, with the final evaluation at study completion, approximately 12 months from enrollment start.

• Turnaround time

  Turnaround time will be measured as the time (in days) from biopsy to the availability of the nanopore sequencing report, compared to the time from biopsy to the finalized pathology report.

  Through study completion, an average of 1 year

Secondary Outcomes (2)

• Quality of Life (QoL) as assessed by the EORTC-QLQ BR-45 questionnaire

  Administered at baseline, 6 months and 12 months.

• Patient Reported Experiences (PREs) with diagnostic procedures using a custom questionnaire

  Administered within 24-48 hours post-biopsy.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with suspected invasive breast cancer undergoing diagnostic workup will be offered to participate.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Bonn: lead
• German Cancer Research Center: collaborator
• Kilimanjaro Christian Medical Centre,Moshi,Tanzania: collaborator

Study Sites (1)

Kilimanjaro Christian Medical Centre

Moshi, P.O. Box 3010, Tanzania

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Excess tissue from SoC diagnosis of suspected invasive breast cancer is preserved for DNA extraction using commercial spin column kits.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Oliver Henke, MD

  Section Global Health, University Hospital Bonn

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Oliver Henke, MD

CONTACT

+49 (0) 228 287 51521; Oliver.Henke@ukbonn.de

Maximilian Rost, MD

CONTACT

+49 (0) 228 287 51521; maximilian.rost@ukbonn.de

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Working Group Global Oncology, Section Global Health, University Hospital Bonn

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 9, 2024
• Study Start: May 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Locations

TA (1)