Health TrialsbyHealthPanel

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

ConditionBreast Cancer Invasive
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Bonn

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Unable to provide informed consent

Patients who have already commenced therapy for BC (except for treatment other than biomedicine, e.g. herbal medicines)

Trial population

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

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Nanopore sequencing

Trial outcomes

Primary outcomes

1

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.

Time frame
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.
2

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.

Time frame
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.
3

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.

Time frame
Through study completion, an average of 1 year

Secondary outcomes

1

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

Quality of Life (QoL) will be measured using the EORTC-QLQ BR-45 questionnaire. The questionnaire will be administered at baseline and at multiple time points during the study, with changes in QoL scores compared over time. It is available in Swahali and in case of illiteracy will be read to the patient.

Time frame
Administered at baseline, 6 months and 12 months.
2

Patient Reported Experiences (PREs) of the healthcare journey

Patient-reported experiences of the healthcare journey, focusing on the number of healthcare visits before biopsy and the time from first symptoms to diagnosis and treatment initiation, will be assessed using a custom questionnaire.

Time frame
Administered within 24-48 hours post-biopsy.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Bonn

Lead sponsor

University Hospital, Bonn

Sponsor institution

German Cancer Research Center

Collaborator

Kilimanjaro Christian Medical Centre,Moshi,Tanzania

Collaborator

Source ClinicalTrials.gov
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